Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Instruments, Instruments Div. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
177 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123178 | STRYKER VENOM ELECTRODES AND CANNULAE | Stryker Instruments, Instruments Div. | 2013-03-28 | 170 | 0 |
| K113477 | IVAS 20MM (10 GAUGE) BALLOON CATHETER | Stryker Instruments, Instruments Div. | 2012-01-06 | 44 | 0 |
| K093419 | IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAU | Stryker Instruments, Instruments Div. | 2010-03-18 | 136 | 0 |
| K072702 | STRYKER ANTIMIC CATHETER | Stryker Instruments, Instruments Div. | 2008-03-19 | 177 | 0 |
| K073017 | STRYKER STRI-SHIELD FLYTE TOGAS | Stryker Instruments, Instruments Div. | 2007-11-30 | 36 | 1 |
| K070078 | STRYKER T4 HYTREL TOGA | Stryker Instruments, Instruments Div. | 2007-02-02 | 24 | 16 |
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