Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sra Developments, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
245 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | Sra Developments, Ltd. | 2022-12-15 | 245 | 0 |
| K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015-07-17 | 84 | 0 |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USC | Sra Developments, Ltd. | 2007-12-19 | 61 | 0 |
| K063531 | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM | Sra Developments, Ltd. | 2007-02-22 | 92 | 0 |
| K032424 | LOTUS | Sra Developments, Ltd. | 2003-12-16 | 133 | 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