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

Cns, Inc. — Predicate Candidate Screening

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

124 daysmedian FDA review time
285 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955711BREATHE RIGHT NASAL STRIPCns, Inc.1996-05-301640
K954914BREATHE RIGHT NASAL STRIPCns, Inc.1996-02-271240
K953772BREATHE RIGHT NASAL STRIPCns, Inc.1995-10-20670
K950273SLEEP TEST(TM)Cns, Inc.1995-09-192390
K921220BREATHE RIGHTCns, Inc.1993-10-075730
K912436AM-PAKCns, Inc.1991-10-181370
K904432SLEEP I/T-5 AND SLEEP I/T-8Cns, Inc.1991-07-102850
K910452RESPI-PAK RT-PAKCns, Inc.1991-04-16740
K901549CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.Cns, Inc.1990-10-242040
K897107POLY G PHYSIOLOGICAL DATA RECORDERCns, Inc.1990-03-12810
K860829CNS 4/8 AND CT 48.1 SOFTWARECns, Inc.1986-05-29850
K860240CNS-EP SYSTEM AND EP 1.0 SOFTWARECns, Inc.1986-04-17840
K854160CNS-16 & LTM 1.0 SOFTWARECns, Inc.1986-01-10910
K844015CEREBRAL TRACER 1500 & CT 1.0 SOFTWARECns, Inc.1984-12-17660

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