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

HFS · Predicate Candidate Screening

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

77 daysmedian FDA review time

186 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K944177	BREAST SHELL	O'Donnell, Byrne & Williams	1994-10-05	40
K944117	AVENT NIPPLE SHIELD	Avent America, Inc.	1994-10-05	43
K935340	COMFORT PLUS NIPPLE SHIELDS	Marshall Baby Products	1994-01-21	77
K935341	COMFORT PLUS BREAST SHELLS	Marshall Baby Products	1994-01-21	77
K930238	BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS	Prolac, Inc.	1993-08-16	209
K923577	BREAST SHELLS	Medela, Inc.	1993-01-22	186
K864176	GENTLE FEEL	Mali, Inc.	1986-11-04	11
K861608	UNICARE BREAST SHELLS	Unicare Medical Products, Inc.	1986-07-15	77
K853176	CANNON BABYSAFE NIPPLE SHIELDS	Medela, Inc.	1985-08-22	41
K840877	ARGYLE ENTERNAL FEEDING BAG W/ADMIN	Sherwood Medical Co.	1984-06-28	122
K833450	NUK BREAST SHIELD	Reliance Products Corp.	1983-11-21	47
K811364	AXICARE BREAST SHELL	Neonatal Corp.	1981-08-03	81

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