Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Standard Bariatrics — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
268 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212728 | Standard Bougie, 38 Fr. and Hand Pump | Standard Bariatrics | 2021-09-23 | 27 | 0 |
| K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021-06-29 | 137 | 0 |
| K210278 | Titan SGS | Standard Bariatrics | 2021-04-28 | 86 | 0 |
| K200517 | Standard Trocar | Standard Bariatrics | 2020-04-09 | 38 | 0 |
| K191885 | Standard Bougie | Standard Bariatrics | 2020-04-08 | 268 | 0 |
| K190788 | Disposable Standard Clamp | Standard Bariatrics | 2019-04-18 | 22 | 0 |
| K181608 | Disposable Standard Clamp | Standard Bariatrics | 2018-09-27 | 100 | 0 |
| K170379 | Disposable Standard Clamp | Standard Bariatrics | 2017-07-19 | 162 | 0 |
| K161720 | Standard Clamp | Standard Bariatrics | 2016-10-24 | 124 | 0 |
| K153358 | Standard Clamp | Standard Bariatrics | 2016-05-02 | 164 | 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