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

Air-Shields Vickers, Inc. — Predicate Candidate Screening

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

126 daysmedian FDA review time
888 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITORAir-Shields Vickers, Inc.1995-02-218880
K924297DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIERAir-Shields Vickers, Inc.1993-03-182040
K912908AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEMAir-Shields Vickers, Inc.1991-12-131640
K912909SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARMAir-Shields Vickers, Inc.1991-11-051260
K912910C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEMAir-Shields Vickers, Inc.1991-10-301200
K904691AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYSTAir-Shields Vickers, Inc.1991-02-191260
K903378MODEL C286 ISOLETTE INFANT INCUBATORAir-Shields Vickers, Inc.1990-10-15770
K895782NEONATAL INCUBATOR (ACCESSORY)Air-Shields Vickers, Inc.1989-12-07710
K884086C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATORAir-Shields Vickers, Inc.1988-11-14480

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