Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GCS — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
135 daysmedian FDA review time
318 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944062 | LAPRASCOPIC GRASPER | Instrument Makar, Inc. | 1995-02-23 | 188 | 0 |
| K944067 | PEANUT WAND, MODIFICATION | Ideal Medical, Inc. | 1994-12-08 | 135 | 0 |
| K933201 | AESCULAP TROCAR INSTRUMENT SET | Aesculap, Inc. | 1993-09-13 | 74 | 0 |
| K932762 | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT | Inman Medical Corp. | 1993-08-31 | 84 | 0 |
| K933371 | IMC ENDOSCOPIC INSTRUMENT HOLDER | Inman Medical Corp. | 1993-08-06 | 28 | 0 |
| K924134 | LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS | Leisegang Medical, Inc. | 1993-07-02 | 318 | 0 |
| K931340 | GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR | Baxter Healthcare Corp | 1993-07-01 | 107 | 0 |
| K925276 | M.I.S. TROCAR-CANNULA | M.I.S. Technology, Inc. | 1993-05-24 | 216 | 0 |
| K921006 | LAPAROSCOPIC RETRACTOR SYSTEM | Laparomed Corp. | 1992-07-28 | 147 | 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