Atlas FDA

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

National Custom Ent., Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
101 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012264MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWCNational Custom Ent., Inc.2001-10-10840
K012263MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024National Custom Ent., Inc.2001-10-10840
K012266SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N72National Custom Ent., Inc.2001-09-12560
K012262BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WCNational Custom Ent., Inc.2001-09-12560
K012259MEDFUSION 2001 & 2010, MODEL N7215IWCNational Custom Ent., Inc.2001-09-12560
K012229SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,National Custom Ent., Inc.2001-09-10560
K943680NCE REPLACEMENT BATTERIESNational Custom Ent., Inc.1994-11-041010
K943632REPLACEMENT BATTERIESNational Custom Ent., Inc.1994-11-041010
K942629NCE REPLACEMENT BATTERIESNational Custom Ent., Inc.1994-08-18760
K941995NCE REPLACEMENT BATTERIESNational Custom Ent., Inc.1994-07-26920
K942244REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLENational Custom Ent., Inc.1994-06-24870
K934067POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/1National Custom Ent., Inc.1993-10-07480

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