Atlas FDA

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

Ideal Medical, Inc. · Predicate Candidate Screening

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

138 daysmedian FDA review time
195 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K944067PEANUT WAND, MODIFICATIONIdeal Medical, Inc.1994-12-081350
K931115HATCHER STONE-EMBOLIS EXTRACTORIdeal Medical, Inc.1993-08-201690
K926335IDEAS PEANUT WANDIdeal Medical, Inc.1993-06-241900
K922161GRICE SOFT TISSUE BIOPSY KITIdeal Medical, Inc.1992-10-131590
K921922GRICE LAPAROSCOPIC SUTURING NEEDLEIdeal Medical, Inc.1992-07-08760
K915175REDDICK RETRACTORIdeal Medical, Inc.1992-04-291660
K914880DUAL BALLOON EMBOLECTOMY CATHETERIdeal Medical, Inc.1992-03-161380
K913602IDEAS' PORTIdeal Medical, Inc.1992-01-021420
K914913GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYSTIdeal Medical, Inc.1991-12-31600
K912540CONTOUR-PORTIdeal Medical, Inc.1991-08-23740
K911601REDDICK TROCAR AND CANNULAIdeal Medical, Inc.1991-05-21410
K910117REDDICK IRRIGATION/ASPIRATION SYSTEMIdeal Medical, Inc.1991-03-19670
K891588TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)Ideal Medical, Inc.1989-09-281950
K891021TRI-LUMEN INTRA VASCULAR BALLOON CATHETERIdeal Medical, Inc.1989-09-182020
K882238VESSEL DILATOR AND INTRODUCER SHEATHIdeal Medical, Inc.1988-08-25900
K812773BENNETT VOLUME VENTILATOR CIRCUITIdeal Medical, Inc.1981-10-23180

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