Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Atom Medical Corporation · Predicate Candidate Screening

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

154 daysmedian FDA review time

314 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K123937	ATOM TRANSCAPSULE V-707	Atom Medical Corporation	2013-05-23	154	0
K120937	SUNFLOWER WARNER	Atom Medical Corporation	2012-07-06	100	0
K111547	BILI-THERAPY PAD TYPE	Atom Medical Corporation	2012-04-12	314	0
K103317	RESUSCITATION UNIT 105	Atom Medical Corporation	2011-04-20	161	0
K102542	RESUSCI FLOW; RESUSCI FLOW 104	Atom Medical Corporation	2011-04-06	215	0
K103828	BILI-THERAPY SPOT TYPE	Atom Medical Corporation	2011-03-29	91	0
K102227	INFA WARMER I	Atom Medical Corporation	2011-01-21	165	0
K102226	DUAL INCU I	Atom Medical Corporation	2011-01-04	148	5
K102279	INCU I	Atom Medical Corporation	2010-12-29	140	0
K102710	NEO-SERVO I	Atom Medical Corporation	2010-12-22	93	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