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

Progressive Dynamics, Inc. — Predicate Candidate Screening

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

110 daysmedian FDA review time
244 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952329LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEMProgressive Dynamics, Inc.1996-01-172440
K944688LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1994-11-01400
K933764LIFE-AIR 1000 PATIENT WARMING COVERProgressive Dynamics, Inc.1993-11-091100
K933593LUMINOUS 150 FIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1993-10-28940
K921866LUMINOUS 250 FIBEROPTIC ILLUMINATORProgressive Dynamics, Inc.1992-07-08790
K914382LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEMProgressive Dynamics, Inc.1992-04-212030
K914383LIFE-AIR 1000 PATIENT WARMING COVERSProgressive Dynamics, Inc.1992-03-301810

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