Integra Lifesciences Production Corporation: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Integra Lifesciences Production Corporation” (first 2021, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 93 days. Since 2017 the median was 93 days, against 103 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 28 |
| 2022 | 1 | 112 |
| 2023 | 2 | 76 |
| 2024 | 2 | 114 |
| 2025 | 2 | 266 |
| 2026 | 1 | 89 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Integra Lifesciences Production Corporation took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 7 | 7 |
| GWM | Device, Monitoring, Intracranial Pressure | 2 | 2 |
Review panels
- Neurology (9)
Most recent Integra Lifesciences Production Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | JXG | 2026-06-23 | 89 |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology | JXG | 2025-08-08 | 267 |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) | JXG | 2025-08-06 | 264 |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | GWM | 2024-02-04 | 139 |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter | JXG | 2024-01-17 | 90 |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | JXG | 2023-12-19 | 60 |
| K223330 | Certas Plus Programmable Valves | JXG | 2023-02-01 | 93 |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves | JXG | 2022-10-14 | 112 |
| K210993 | CereLink ICP Monitor | GWM | 2021-04-30 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Integra Lifesciences Production Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Integra LifeSciences Corporation (94 510(k)s)
- Integra Neurocare, LLC (12 510(k)s)
- Integra Radionics, Inc. (10 510(k)s)
- Integra Neurosciences (9 510(k)s)
- Integra Neurosciences Implants S.A. (6 510(k)s)
- Integra Life Sciences (3 510(k)s)
- Integra Lifescience Corportation (2 510(k)s)
- Integra Medical (2 510(k)s)
- Integra Biotechnical, LLC (1 510(k)s)
- Integra Burlington Ma, Inc. (1 510(k)s)
- Integra Burlington Ma, Inc. (Formerly Integra Radi (1 510(k)s)
- Integra Lifesciences Corporation (Owner of Tei Biosciences) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Integra Lifesciences Production Corporation?
FDA lists 9 510(k) clearances under the applicant name “Integra Lifesciences Production Corporation” (first 2021, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Integra Lifesciences Production Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Integra Lifesciences Production Corporation is 93 days. Since 2017: 93 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Integra Lifesciences Production Corporation?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 7); GWM (Device, Monitoring, Intracranial Pressure, 2).
Next steps
- See all 9 Integra Lifesciences Production Corporation clearances with predicates and recalls
- Run predicate analysis for product code JXG, Integra Lifesciences Production Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.