Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

I.C Medical, Inc. · Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

152 daysmedian FDA review time
307 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163659Crystal VisionI.C Medical, Inc.2017-10-303070
K160160Non-Telescopic PenEvacI.C Medical, Inc.2016-04-05690
K003840CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIESI.C Medical, Inc.2001-02-01510
K960492SI CONTROLLER MODEL SI 500I.C Medical, Inc.1996-12-233250
K961616TELESCOPING PENEVAC (MODIFICATION)I.C Medical, Inc.1996-05-28360
K955166PENEVAC SI.I.C Medical, Inc.1996-04-111500
K955020PENEVAC ABC HANDPIECEI.C Medical, Inc.1996-04-091590
K953418ELECTROCAUTERY SHROUDI.C Medical, Inc.1995-10-07850
K954088TELESCOPING PENEVACI.C Medical, Inc.1995-09-22220
K932230CRYSTAL VISION AND ACCESSORIESI.C Medical, Inc.1994-02-182870
K930099LASER HANDPIECE SHROUDI.C Medical, Inc.1993-07-282010
K930098SPECULUM SMOKE EVACUATOR TUBINGI.C Medical, Inc.1993-07-282010
K930097ELECTROCAUTERY SHROUDI.C Medical, Inc.1993-07-282010
K914118I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATORI.C Medical, Inc.1992-02-121520
K902611I.C. MEDICAL SMOKE EVACUATOR ACTIVATORI.C Medical, Inc.1990-08-17650
K900511I.C. MEDICAL ADJUSTABLE DIRECT COUPLERI.C Medical, Inc.1990-05-01880

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