Atlas FDA

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

BSB · Predicate Candidate Screening

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

56 daysmedian FDA review time
211 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K112639THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.2011-11-16650
K090508THE BELMONT BUDDY LITE FLUID WARMERBelmont Instrument Corp.2009-03-26280
K062774BELMONT BUDDY PLUS FLUID WARMERBelmont Instrument Corp.2006-10-19310
K052547BELMONT BUDDY FLUID WARMERBelmont Instrument Corp.2005-10-13270
K031478MICROHEATERBelmont Instrument Corp.2003-07-02510
K020060ASTOFLONats Corp.2002-03-05560
K012031MODIFICATION TO THERMAL ANGELEstill Medical Technologies, Inc.2001-07-26281
K991159PRISMATHERM II, ASTOLINEStihler Electronic GmbH1999-09-031490
K991160ASTOTHERM PLUS, ASTOTUBES, ASTOLINEStihler Electronic GmbH1999-09-021480
K984640THERMAL ANGELEstill Medical Technologies, Inc.1999-07-011821
K973741BAIR HUGGER BLOOD/FLUID WARMERAugustine Medical, Inc.1998-04-302113
K953741THERMACYL BLOOD/FLUID WARMERBaxter Healthcare Corp1996-06-263210
K770232BLOOD/FLUID WARMER MODEL DW-1000AGorman Rupp Industries1977-02-1470
K760012BLOOD WARMER (CODE 4R4305)Travenol Laboratories, S.A.1976-07-16360

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