Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Life Shield Healthcare Products, Inc. · Predicate Candidate Screening

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

57 daysmedian FDA review time
57 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932562GAS SAMPLING LINES AND CONNECTORSLife Shield Healthcare Products, Inc.1993-07-23570
K932557HYPERINFLATION SYSTEMLife Shield Healthcare Products, Inc.1993-07-22560
K932558ADULT ANESTHESIA BREATHING CIRCUITLife Shield Healthcare Products, Inc.1993-07-22560
K932560VOLUME VENTILATORSLife Shield Healthcare Products, Inc.1993-07-22560
K932561GUEDEL AIRWAYSLife Shield Healthcare Products, Inc.1993-07-22560
K932559MAPLESON D CIRCUITSLife Shield Healthcare Products, Inc.1993-07-16500
K932563VENTILATOR HOSESLife Shield Healthcare Products, Inc.1993-07-16500
K932190ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITSLife Shield Healthcare Products, Inc.1993-07-02570
K932191BREATHING BAGSLife Shield Healthcare Products, Inc.1993-07-02570
K932192PEDIATRIC ANESTHESIA CIRCUITSLife Shield Healthcare Products, Inc.1993-07-02570
K932193PEDIATRIC TEMPERATURE MONITORING CIRCUITSLife Shield Healthcare Products, Inc.1993-07-02570
K932194PEDIATRIC GASSAMPLING CIRCUITSLife Shield Healthcare Products, Inc.1993-07-02570
K932195ADULT GAS SAMPLING CIRCUITSLife Shield Healthcare Products, Inc.1993-07-02570
K932196COAXIAL CIRCUITSLife Shield Healthcare Products, Inc.1993-07-02570
K932197CUSTOM ANESTHESIA CIRCUITSLife Shield Healthcare Products, Inc.1993-07-02570
K925388LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTERLife Shield Healthcare Products, Inc.1993-05-111970
K931036CONNECTORS AND AIRWAY EXTENSIONSLife Shield Healthcare Products, Inc.1993-04-08380

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