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

Warren E. Collins, Inc. — Predicate Candidate Screening

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

77 daysmedian FDA review time
194 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K925459GS-MODULAR (GOLD STANDARD - MODULAR)Warren E. Collins, Inc.1994-02-044630
K912946COLLINS DIGITAL PULMONARY MANOMETERWarren E. Collins, Inc.1992-01-151940
K871151THE SPIRA ELEKTRO 2Warren E. Collins, Inc.1987-05-15530
K861227COLLINS PNEUMOTACH PFT SYSTEMWarren E. Collins, Inc.1986-06-05650
K852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMWarren E. Collins, Inc.1985-07-31770
K831780METABOLIC EXERCISE TESTING SYSTEMWarren E. Collins, Inc.1983-09-121020
K831777COLLINS DSWarren E. Collins, Inc.1983-08-31900
K831778RS-RESIDUAL VOLUME SYSTEMWarren E. Collins, Inc.1983-08-31900
K831779COLLINS EAGLE IIWarren E. Collins, Inc.1983-08-26850
K803069SHELL KRATON THERMO-PLASTIC RUBBER COMP.Warren E. Collins, Inc.1980-12-22170
K803053APEXLINE OF PULMONARY FUNCT. INSTRUM.Warren E. Collins, Inc.1980-12-22200
K781889COLLINS PEDALMATE 2Warren E. Collins, Inc.1978-11-22150
K780584PULMONARY FUNCTION TESTERWarren E. Collins, Inc.1978-05-16350
K780328PULMONARY FUNCTION TESTER, COMPUTERIZEDWarren E. Collins, Inc.1978-03-14150

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