Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Integra Lifesciences Production Corporation · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
93 daysmedian FDA review time
267 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682 | Integra Lifesciences Production Corporation | 2026-06-23 | 89 | 0 |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo Tec | Integra Lifesciences Production Corporation | 2025-08-08 | 267 | 0 |
| K243552 | Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and End | Integra Lifesciences Production Corporation | 2025-08-06 | 264 | 0 |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable | Integra Lifesciences Production Corporation | 2024-02-04 | 139 | 1 |
| K233445 | Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bac | Integra Lifesciences Production Corporation | 2024-01-17 | 90 | 0 |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Se | Integra Lifesciences Production Corporation | 2023-12-19 | 60 | 3 |
| K223330 | Certas Plus Programmable Valves | Integra Lifesciences Production Corporation | 2023-02-01 | 93 | 1 |
| K221840 | Hakim Programmable Valves, Hakim Precision Fixed Pressure Va | Integra Lifesciences Production Corporation | 2022-10-14 | 112 | 0 |
| K210993 | CereLink ICP Monitor | Integra Lifesciences Production Corporation | 2021-04-30 | 28 | 2 |
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