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

Hill-Rom Air-Shields · Predicate Candidate Screening

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

86 daysmedian FDA review time

320 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021622	HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103	Hill-Rom Air-Shields	2003-04-01	320	0
K003335	RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARM	Hill-Rom Air-Shields	2000-11-17	23	1
K001242	ISOLETTE INFANT INCUBATOR, MODEL C2HS	Hill-Rom Air-Shields	2000-07-13	86	0
K001019	TI500 GLOBE-TROTTER TRANSPORT SYSTEM	Hill-Rom Air-Shields	2000-04-27	28	2
K993051	VERSALET 7700 CARE CENTER, MODEL # 7700	Hill-Rom Air-Shields	2000-02-03	143	0

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