Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S.H.Pitkar Orthotools Pvt. , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
200 daysmedian FDA review time
230 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2024-09-09 | 224 | 0 |
| K200728 | Pitkar DeftFix System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-10-06 | 200 | 0 |
| K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-07-29 | 149 | 0 |
| K192619 | Pitkar Locked Plating System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2020-02-27 | 157 | 0 |
| K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt. , Ltd. | 2019-10-16 | 230 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda