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

Intec Medical, Inc. — Predicate Candidate Screening

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

50 daysmedian FDA review time
166 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K911840INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETERIntec Medical, Inc.1991-06-03390
K903217TAPERED TIP THE GUIDER CORONARY GUIDING CATHETERIntec Medical, Inc.1990-10-19880
K903216THE GUIDER CORONARY GUIDING CATHETERIntec Medical, Inc.1990-10-19880
K900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETERIntec Medical, Inc.1990-10-192470
K903840GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSYIntec Medical, Inc.1990-10-16560
K903906PERCUTANEOUS CATHETER INTRODUCER KITIntec Medical, Inc.1990-09-26340
K900998INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVEIntec Medical, Inc.1990-08-141660
K901247TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVESIntec Medical, Inc.1990-07-311380
K894925AMCATH URETERAL DILATORS MODELS 7100,7110,7120Intec Medical, Inc.1989-12-131330
K860941DISPOSABLE HEATED WIRE LOOPS 48 AND 72Intec Medical, Inc.1986-04-02210
K823271DISPOSABLE ADULT VO. VENTILATOR CIRCUITIntec Medical, Inc.1982-12-22500
K813317DISP. HYPERINFLATION BAG SYSTEMIntec Medical, Inc.1982-03-121080
K810621DISPOSABLE 22MM. FLEXIBLE ADAPTORIntec Medical, Inc.1981-04-17390
K810620DISPOSABLE ELBOW ADAPTORIntec Medical, Inc.1981-03-20110
K801261DISPOSABLE COUPLING ADAPTORIntec Medical, Inc.1980-06-09120
K801260DISPOSABLE PRESSURE LINE ADAPTORIntec Medical, Inc.1980-06-0470
K800562DISPOSABLE HAND HELD NEBULIZERIntec Medical, Inc.1980-03-25130

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