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

Protocol Systems, Inc. — Predicate Candidate Screening

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

98 daysmedian FDA review time
362 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002725MICROPAQ, MODELS 402 AND 404Protocol Systems, Inc.2000-11-21820
K972121ACUITY CENTRAL STATIONProtocol Systems, Inc.1997-11-071550
K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEProtocol Systems, Inc.1996-02-023190
K945071PROPAQ 200 MONITORProtocol Systems, Inc.1995-05-102080
K935846MODEL ACUITY CENTRAL STATIONProtocol Systems, Inc.1994-12-053620
K934711PROPAQ ECG TELEMETRY OPTIONProtocol Systems, Inc.1994-09-013350
K921497PROPAQ MONITORS, MODIFICATIONProtocol Systems, Inc.1993-03-233770
K914838PROPAQ 102,104,106,102EL,104EL,&106ELProtocol Systems, Inc.1992-01-10770
K913193MODEL 100 CENTRAL STATIONProtocol Systems, Inc.1991-10-16900
K910882PROPAQ 102EL, 104EL AND 106ELProtocol Systems, Inc.1991-05-08680
K910772PROPAQ 102, 104 AND 106Protocol Systems, Inc.1991-04-12490
K902730SPO2 OPTIONProtocol Systems, Inc.1990-10-221230
K894607PAQ10 PAPER CHART RECORDERProtocol Systems, Inc.1989-10-26980
K884320PROPAQ 106(TM)Protocol Systems, Inc.1988-12-27750
K882085PROPAQ 104(TM)Protocol Systems, Inc.1988-07-28710

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