Atlas FDA

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

Egnell, Inc. — Predicate Candidate Screening

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

83 daysmedian FDA review time
140 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K853917EGNELL COMPACT SUCTION PUMPEgnell, Inc.1985-11-25630
K853909EGNELL UNIVERSAL SUCTION PUMPEgnell, Inc.1985-11-25660
K844307EGNELL-LACT B BATTERY-OPERATED BREAST PUMPEgnell, Inc.1985-02-04980
K840526AMETHERMEgnell, Inc.1984-04-30830
K834335AMEDA PHOTOTHERAPY LAMP FOR NEWBORNEgnell, Inc.1984-04-201300
K832637AMEDA NEONATAL RESUSCITATION UNIT-Egnell, Inc.1983-12-221400
K813312UNIVERSAL SUCTION PUMP TYPE EUSEgnell, Inc.1981-12-31370
K813095GASTRIC JUICES SUCTION PUMPEgnell, Inc.1981-12-09360
K812898PE-01 ELECTRONIC INFUSION PUMPEgnell, Inc.1981-12-02470
K812020EGNELL COMPACT, TYPE EHVEgnell, Inc.1981-10-20920

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