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

Mcgaw Respiratory Therapy · Predicate Candidate Screening

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

9 daysmedian FDA review time

39 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K771550	MRT DISPENSOR	Mcgaw Respiratory Therapy	1977-09-20	39
K771516	CAPILLARY SAMPLE LINE	Mcgaw Respiratory Therapy	1977-08-16	8
K770665	VALVE, PRESSURE, DEMAND	Mcgaw Respiratory Therapy	1977-04-15	7
K770286	VENTILATOR BREATHING CIRCUIT	Mcgaw Respiratory Therapy	1977-02-25	11
K761299	DISPOSABLE NEBULIZER	Mcgaw Respiratory Therapy	1976-12-30	9
K761298	PRE-FILLED DISPOSABLE NEBULIZER	Mcgaw Respiratory Therapy	1976-12-30	9
K761300	NEBULIZER CONTROL UNIT	Mcgaw Respiratory Therapy	1976-12-30	9
K760998	ENDOTRACHAEL TUBE AND HOLDER	Mcgaw Respiratory Therapy	1976-11-19	11

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