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

Matheson Gas Products, Inc. · Predicate Candidate Screening

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

32 daysmedian FDA review time
44 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K882516THREE-COMPONENT MEDICAL LASER GAS MIXTURESMatheson Gas Products, Inc.1988-08-03440
K871100O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USPMatheson Gas Products, Inc.1987-04-21330
K871102O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NFMatheson Gas Products, Inc.1987-04-20320
K8711010.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.Matheson Gas Products, Inc.1987-04-20320
K871103O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.PMatheson Gas Products, Inc.1987-04-20320

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