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Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Prima, Inc. — Predicate Candidate Screening

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

24 daysmedian FDA review time
78 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952014PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSPrima, Inc.1995-05-22240
K952010PRIMA VENTILATOR HOSESPrima, Inc.1995-05-22240
K952013PRIMA GUEDEL AIRWAYSPrima, Inc.1995-05-22240
K952019PRIMA ADULT GAS SAMPLING CIRCUITSPrima, Inc.1995-05-22240
K952018PRIMA COAXIAL CIRCUITSPrima, Inc.1995-05-22240
K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.1995-05-22240
K952021PRIMA HYUPERINFLATION SYSTEMPrima, Inc.1995-05-22240
K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.1995-05-22240
K952017PRIMA MAPLESON D CIRCUITPrima, Inc.1995-05-22240
K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, Inc.1995-05-22240
K952011PRIMA BREATHING BAGSPrima, Inc.1995-05-22240
K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, Inc.1995-05-22240
K952015PRIMA FILTERPrima, Inc.1995-05-22240
K952009PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITSPrima, Inc.1995-05-19210
K944531PRIMA, INC. CORRUGATED TUBINGPrima, Inc.1994-12-02780
K944532PRIMA, INC. VENTILATOR HOSESPrima, Inc.1994-12-02780
K944535PRIMA, INC. GAS SAMPLING LINES AND CONNECTORSPrima, Inc.1994-11-29750
K944534PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONSPrima, Inc.1994-11-29750
K944533PRIMA, INC. ADULT ANESTHESIA CIRCUITPrima, Inc.1994-11-29750

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