FDA applicant
Response Ortho Solutions, LLC
FDA records 3 decisions for Response Ortho Solutions, LLC (Boynton Beach, FL) from 2024 to 2026: 3 510(k) clearances. All are in product code KTT (Appliance, Fixation, Nail/Blade/Plate…). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Response Ortho Solutions, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Response Ortho Solutions, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Response”
FDA records each applicant name separately; these may or may not be the same firm.