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

Bird Life Design — Predicate Candidate Screening

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

90 daysmedian FDA review time

267 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K931487	BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE	Bird Life Design	1993-12-16	267	0
K934189	BARRIERFLEX-I, AND BARRIERFLES-II	Bird Life Design	1993-11-24	90	0
K934190	HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION	Bird Life Design	1993-11-24	90	0
K934540	BARRIERFLEX-PF PULMONARY FUNCTION TESTING FILTER	Bird Life Design	1993-10-19	33	0
K933641	BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIB	Bird Life Design	1993-10-15	80	0
K925543	BLD-18000 SERIES HEATED BREATHING CIRCUIT	Bird Life Design	1993-04-30	176	0
K930252	BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)	Bird Life Design	1993-02-09	32	6

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