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

Intl. Medical Devices , Ltd. — Predicate Candidate Screening

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

72 daysmedian FDA review time

244 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K913541	NEO-THOR THORACOSTOMY KIT	Intl. Medical Devices , Ltd.	1992-04-09	244
K913540	PEDIA-THOR THORACOSTOMY KIT	Intl. Medical Devices , Ltd.	1992-04-09	244
K913542	THORACIC CATHETER WITH GUIDE	Intl. Medical Devices , Ltd.	1992-01-21	165
K913539	THORACIC CATHTER STYLET	Intl. Medical Devices , Ltd.	1992-01-21	165
K913543	THORACIC CATHETER STYLET	Intl. Medical Devices , Ltd.	1991-10-04	56
K862909	RE-TRAKE WEISS EMERGENCY AIRWAY & THORACIC SYSTEM	Intl. Medical Devices , Ltd.	1986-09-09	40
K850398	NU-CATH EMERGENCY KIT	Intl. Medical Devices , Ltd.	1985-03-27	54
K843785	WISSS PEDIATRIC TRACH- TUBE W/OBTURATOR	Intl. Medical Devices , Ltd.	1984-10-23	26
K842666	NU-THOR THORACOSTOMY KIT	Intl. Medical Devices , Ltd.	1984-09-20	72
K840925	PEDIA-TRAKE CRICOTHYROTOMY KIT	Intl. Medical Devices , Ltd.	1984-05-02	61
K820778	RESPIRATION MONITOR 1000	Intl. Medical Devices , Ltd.	1982-05-03	41
K790650	WEISS EMERGENCY AIRWAY SYSTEM	Intl. Medical Devices , Ltd.	1979-06-27	85

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