# Standard Bariatrics

- Location (FDA's records): Cincinnati, OH
- FDA decisions: 12 (2016–2023): 12 510(k) clearances
- Names in FDA's records: Standard Bariatrics (10); Standard Bariatrics, Inc. (2)
- Product codes: GCJ (5), KNT (4), OXC (1), GDW (1), GDJ (1)
- 510(k) review time since 2016: median 104 days, against 101 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Applied Medical Resources: 2 (https://510kreport.com/company/applied-medical-resources)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Boehringer Laboratories: 1 (https://510kreport.com/company/boehringer-laboratories)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)

## Its most-cited devices
- K210437: Standard Bougie, 38 Fr. (2021), cited by 2
- K153358: Standard Clamp (2016), cited by 1
- K170379: Disposable Standard Clamp (2017), cited by 1
- K191885: Standard Bougie (2020), cited by 1
- K161720: Standard Clamp (2016), cited by 1

## Recent decisions
- K231603: Standard Staple-Line Reinforcement (SSLR23) (Oct 6, 2023)
- K222085: Standard Tapered Bougie, 38 Fr. (Oct 31, 2022)
- K212728: Standard Bougie, 38 Fr. and Hand Pump (Sep 23, 2021)
- K210437: Standard Bougie, 38 Fr. (Jun 29, 2021)
- K210278: Titan SGS (Apr 28, 2021)
- K200517: Standard Trocar (Apr 9, 2020)
- K191885: Standard Bougie (Apr 8, 2020)
- K190788: Disposable Standard Clamp (Apr 18, 2019)

Source page: https://510kreport.com/company/standard-bariatrics