Atlas FDA

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

Drager, Inc. — Predicate Candidate Screening

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

222 daysmedian FDA review time
597 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992608ATC OPTION FOR EVITA 2 DURA AND EVITA 4Drager, Inc.1999-08-24200
K984577DRAGER OXYLOG 2000Drager, Inc.1999-01-22300
K983219NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900Drager, Inc.1998-12-07840
K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419Drager, Inc.1998-10-29801
K980642EVITA 4 (8411900)Drager, Inc.1998-09-041970
K974176BABYLOG 8000 PLUSDrager, Inc.1998-06-172231
K971198BABYTHERM 8004 BABYTHERM 8010Drager, Inc.1997-10-031860
K970165EVITA 2 DURADrager, Inc.1997-08-262220
K954204DRAGER INCUBATOR 8000 ICDrager, Inc.1997-04-255970
K961687EVITA 4Drager, Inc.1996-12-132260
K950853OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORSDrager, Inc.1996-11-056170
K953238DRAGER MICRO VENTDrager, Inc.1996-09-164330
K953489DRAGER INFANT RADIANT WARMERN RH600Drager, Inc.1996-02-091990
K954611DRAGER PT4000 PHOTOTHERAPY SYSTEMDrager, Inc.1995-12-01581
K943531OXYLOG 2000Drager, Inc.1995-08-254000
K945467BABYTHERM 8000 WBDrager, Inc.1995-04-281720
K951126DRAGER MEDICAL AIR COMPRESSORDrager, Inc.1995-03-24110
K926292BABYLOG 8000 INFANT VENTILATORDrager, Inc.1994-04-194910
K924930EVITADrager, Inc.1994-01-104670
K903089BABYLOG 8000 INFANT VENTILATORDrager, Inc.1991-06-103320

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