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

Spirometrics, Inc. — Predicate Candidate Screening

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

49 daysmedian FDA review time
116 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K915059PEAK FLOW MONITORSpirometrics, Inc.1992-07-272620
K911358CMD/DLCO DIAGNOSTIC SPIROMETERSpirometrics, Inc.1991-07-221160
K900322CO/CMD-1Spirometrics, Inc.1990-04-30970
K901057SPIROMETRICS MODEL 2600 MIRO SPIROMETERSpirometrics, Inc.1990-04-03280
K900673SERIAL FLOWSpirometrics, Inc.1990-04-03490
K884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSORSpirometrics, Inc.1989-01-19870
K884465SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)Spirometrics, Inc.1988-11-09160
K863953SPIROMETRICS MODEL 2500 FLOWMATE(TM)Spirometrics, Inc.1987-01-15970
K850045SPIROMETRICS 2453 & SMI IIISpirometrics, Inc.1985-02-14380
K844333SPIROMETRICS 2451 & SMI ISpirometrics, Inc.1984-11-20130
K831497SPIROMETRICS BREON 2400 & SMI 2400Spirometrics, Inc.1983-06-24450

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