510k Services Marketplace — Compare Providers & Get Quotes

FDA 510(k) submission services are professional offerings that help manufacturers bring Class I and Class II medical devices to the U.S. market^[1]. Per FDA guidance, a 510(k) is a premarket notification demonstrating that a new device is substantially equivalent to a legally marketed predicate device^[1]. Most Class II devices require 510(k) clearance before commercial distribution in the United States^[2].

510k services typically include: pathway and classification (confirming 510(k) vs De Novo vs PMA); predicate research and substantial equivalence strategy; evidence planning (testing, standards, labeling); authoring and assembly of the submission, often using FDA's eSTAR electronic template^[3]; Pre-Sub / Q-Sub preparation when you want FDA feedback first^[4]; and RTA remediation if FDA refuses-to-accept the submission for administrative incompleteness^[5]. Comparing 510k services providers helps you find the right scope, pricing, and turnaround for your device.

Per FDA regulations and guidance, teams preparing a U.S. market submission often need 510k services when: pathway or classification is unclear; predicate selection and substantial equivalence rationale require expertise; evidence planning (testing, standards, labeling) is complex; or internal bandwidth is limited^[1].

Typical situations:

• First 510(k) — no in-house experience with eSTAR, RTA checklists, or FDA expectations
• Tight timelines — need a partner to draft, assemble, and quality-check the submission
• Novel technology or unclear predicate — want Pre-Sub support before committing to a full 510(k)^[2]
• RTA received — need remediation to address FDA's refuse-to-accept letter and resubmit^[3]
• Modification to a cleared device — need to determine if a new 510(k) is required and which pathway (Traditional, Special, Abbreviated)

Per FDA guidance and common practice, 510k services scope varies by provider; common elements^[1]:

• Pathway + classification: Aligning regulatory pathway (510(k) vs De Novo vs PMA) and device classification (Class I/II/III)^[2].
• Predicate + evidence planning: Substantial equivalence strategy, predicate device research, and evidence mapping (testing, standards, labeling).
• Authoring + assembly: Drafting key sections and assembling the submission package, often in eSTAR^[3].
• Regulator interaction: Pre-Sub / Q-Sub packages and meeting support when you want FDA feedback before full submission^[4].
• RTA remediation: Addressing refuse-to-accept issues and resubmitting to meet FDA administrative completeness^[5].

510k services pricing depends on scope, complexity, timeline, and your inputs; scope and complexity are driven by FDA pathway and evidence expectations^[1]:

• Scope: Strategy-only vs full authoring vs end-to-end project management (evidence coordination, labeling, eSTAR assembly, Pre-Sub, RTA remediation).
• Complexity: Device risk/class, novel technology, number of predicates, evidence gaps (e.g. missing testing or clinical data).
• Timeline: Expedited or rush timelines generally increase cost.
• Inputs: How complete your drafts, evidence, and labeling are — more complete inputs can reduce authoring hours.

Request a clear deliverables list and pricing model (fixed package vs hourly vs retainer) when comparing 510k services providers.

When comparing 510k services providers, use this checklist:

• Deliverables clarity: Ask for a deliverables checklist and acceptance criteria (submission plan, draft sections, eSTAR package, handover artifacts).
• Predicate strategy: Confirm how they perform predicate research and defend substantial equivalence rationale^[1].
• eSTAR workflow: Confirm eSTAR experience and tooling/process^[2] — FDA encourages eSTAR for 510(k) submissions.
• RTA readiness: Ask how they prevent RTAs (e.g. completeness check against FDA RTA checklist) and handle remediation^[3].
• Project management: Confirm roles, timeline, and handoff artifacts (evidence matrix, meeting package if Pre-Sub used).

Per FDA regulations, a 510(k) is required when you intend to market a new device that is subject to premarket notification under section 510(k) of the FD&C Act and 21 CFR Part 807^[1]. In practice, this applies to most Class II medical devices and some Class I devices that are not exempt^[2].

Common triggers:

• New device — first commercial distribution in the U.S.; no predicate by the same manufacturer
• Modification to a cleared device — when the change could affect safety or effectiveness, FDA may require a new 510(k)^[1]
• Device not substantially equivalent to a predicate — may need De Novo or PMA instead; 510k services providers can help scope the pathway^[3]

FDA's Device Classification database and product codes help determine whether your device is 510(k)-exempt or requires a submission^[2]. When in doubt, many teams use a 510k services provider or Pre-Sub to confirm.

FDA clears a 510(k) when the new device is determined to be substantially equivalent (SE) to a legally marketed predicate device^[1]. Per FDA guidance, substantial equivalence means the new device has the same intended use as the predicate and either the same technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness and are demonstrated to be as safe and effective as the predicate^[1][2].

Key elements 510k services providers help with:

• Predicate selection — identifying a suitable predicate (same product code, intended use, and comparable technology where possible)^[1]
• SE rationale — drafting the substantial equivalence comparison and addressing any different technological characteristics with benefit-risk analysis where needed^[2]
• Evidence mapping — aligning testing, standards, and labeling with FDA expectations for the device type

FDA's guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" describes the regulatory framework and decision points^[1]. When devices have different technological characteristics, FDA's benefit-risk guidance may apply^[2].

FDA reviews 510(k) submissions according to procedures and performance goals described in guidance^[1]. The 510(k) submission process typically involves: receipt and administrative completeness review (RTA check); substantive review; and a decision (substantially equivalent, not substantially equivalent, or additional information requested)^[2].

Review clock and goals: FDA and industry actions (e.g. submission of additional information, FDA hold letters) affect the review clock and published performance goals^[1]. Under MDUFA, FDA commits to performance targets for 510(k) reviews; actual time to decision depends on submission quality, device complexity, and whether FDA requests additional information.

How 510k services help: Providers that perform RTA readiness checks and assemble complete, eSTAR-formatted submissions can reduce the risk of RTA and deficiency cycles, supporting a smoother path to clearance^[3].