Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Birtcher Medical Systems, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
279 daysmedian FDA review time
439 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932779 | BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. | Birtcher Medical Systems, Inc. | 1995-03-21 | 651 | 0 |
| K944681 | LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES | Birtcher Medical Systems, Inc. | 1994-12-22 | 91 | 0 |
| K931654 | BIRTCHER MAGNETIC RETRIEVER (GS-3100) | Birtcher Medical Systems, Inc. | 1994-04-25 | 385 | 0 |
| K930887 | BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600) | Birtcher Medical Systems, Inc. | 1994-04-25 | 430 | 0 |
| K936114 | BIRTCHER PERICARDIAL KNIVES | Birtcher Medical Systems, Inc. | 1994-04-25 | 439 | 0 |
| K931771 | BIRTCHER ENDOSCOPIC CORKSCREW | Birtcher Medical Systems, Inc. | 1994-04-25 | 381 | 0 |
| K932987 | BIRTCHER LAPAROSCOPE AND ACCESSORIES | Birtcher Medical Systems, Inc. | 1994-04-25 | 311 | 0 |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE | Birtcher Medical Systems, Inc. | 1993-10-27 | 112 | 0 |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 | 279 | 0 |
| K930496 | GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS | Birtcher Medical Systems, Inc. | 1993-04-20 | 78 | 0 |
| K925824 | SOLOS FAN RETRACTORS | Birtcher Medical Systems, Inc. | 1993-03-01 | 104 | 0 |
| K925903 | LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION | Birtcher Medical Systems, Inc. | 1992-12-30 | 48 | 4 |
| K910889 | ABC LAPAROSCOPIC HANDPROBE | Birtcher Medical Systems, Inc. | 1991-08-29 | 178 | 0 |
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