FDA applicant
S.H.Pitkar Orthotools Pvt., Ltd.
FDA records 5 decisions for S.H.Pitkar Orthotools Pvt., Ltd. (Pune, IN) from 2019 to 2024: 5 510(k) clearances. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 200 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 19 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 S.H.Pitkar Orthotools Pvt., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like S.H.Pitkar Orthotools Pvt., Ltd.’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) Report