Atlas FDA

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

CAM · Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

84 daysmedian FDA review time
134 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K935283YOKE ASSEMBLY MEDICAL GASAmerican Gage & Medical, Inc.1994-03-111280
K851215T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTERPenox Technologies, Inc.1985-06-18840
K851216PENOX DUAL FEED MANIFOLDPenox Technologies, Inc.1985-06-18840
K851217PENOX DUAL FLOW MINIFOLDPenox Technologies, Inc.1985-06-18840
K851219FILL HOSE SAFETY ADAPTERPenox Technologies, Inc.1985-06-18840
K840326GAS SUPPLY MANIFOLD SIEMENS-ELEMA ABSiemens Elema AB1984-06-071340
K780365OXYGEN/NITROUS OXIDE OUTLETSpica, Inc.1978-03-30240
K770426OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDEBel-Med, Inc.1977-03-1580

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