Standard Bariatrics: FDA clearances and approvals
Standard Bariatrics has 12 FDA 510(k) clearances (first 2016, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time: 116 days. Since 2017 its median was 104 days, against 105 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 144 |
| 2017 | 1 | 162 |
| 2018 | 1 | 100 |
| 2019 | 1 | 22 |
| 2020 | 2 | 153 |
| 2021 | 3 | 86 |
| 2022 | 1 | 108 |
| 2023 | 1 | 127 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Standard Bariatrics's cleared 510(k)s took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 4 | 4 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| OXC | Mesh, Surgical, Absorbable, Staple Line Reinforcement | 1 | 1 |
Review panels
Most recent Standard Bariatrics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231603 | Standard Staple-Line Reinforcement (SSLR23) | OXC | 2023-10-06 | 127 |
| K222085 | Standard Tapered Bougie, 38 Fr. | KNT | 2022-10-31 | 108 |
| K212728 | Standard Bougie, 38 Fr. and Hand Pump | KNT | 2021-09-23 | 27 |
| K210437 | Standard Bougie, 38 Fr. | KNT | 2021-06-29 | 137 |
| K210278 | Titan SGS | GDW | 2021-04-28 | 86 |
| K200517 | Standard Trocar | GCJ | 2020-04-09 | 38 |
| K191885 | Standard Bougie | KNT | 2020-04-08 | 268 |
| K190788 | Disposable Standard Clamp | GCJ | 2019-04-18 | 22 |
| K181608 | Disposable Standard Clamp | GCJ | 2018-09-27 | 100 |
| K170379 | Disposable Standard Clamp | GCJ | 2017-07-19 | 162 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Standard Bariatrics.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Standard Bariatrics is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04347837: Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection (Completed, started 2020-07-02)
- NCT04086433: Gastric Tissue Stapler Comparison Study (Completed, started 2019-07-15)
Frequently asked questions
How many FDA 510(k) clearances does Standard Bariatrics have?
Standard Bariatrics has 12 FDA 510(k) clearances (first 2016, latest 2023), across 5 product codes in 2 review panels.
How long does FDA take to clear Standard Bariatrics's 510(k)s?
The median time from FDA receipt to decision across Standard Bariatrics's cleared 510(k)s is 116 days. Since 2017: 104 days, versus 105 days for all cleared 510(k)s in the same product codes.
What devices does Standard Bariatrics make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 5); KNT (Tubes, Gastrointestinal (And Accessories), 4); GDJ (Clamp, Surgical, General & Plastic Surgery, 1).
Has Standard Bariatrics had device recalls?
openFDA lists no recalls under a recalling firm name matching Standard Bariatrics. Related entities may recall under other names.
Next steps
- See all 12 Standard Bariatrics clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Standard Bariatrics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.