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

Specialty Packaging Producs, Inc. — Predicate Candidate Screening

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

83 daysmedian FDA review time
183 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922492SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERSpecialty Packaging Producs, Inc.1992-08-24890
K913163NON REBREATHING VALVESpecialty Packaging Producs, Inc.1992-02-032010
K913422OXYGEN TUBING, 81503Specialty Packaging Producs, Inc.1992-01-301830
K913216TRACH T ADAPTERSpecialty Packaging Producs, Inc.1992-01-151800
K913164NON REBREATHING MASKSpecialty Packaging Producs, Inc.1992-01-151820
K913383OXYGEN MASKS 81420, 81421, 81471 & 81461Specialty Packaging Producs, Inc.1991-10-18810
K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589Specialty Packaging Producs, Inc.1991-10-18790
K913220AEROSOL MASKS, 81426, 81476, 81490 & 81492Specialty Packaging Producs, Inc.1991-10-10830
K913275VENTURI OXYGEN MASKSpecialty Packaging Producs, Inc.1991-10-10790
K913455OXYGEN MASKS 82400 & 82405Specialty Packaging Producs, Inc.1991-10-02610
K910896DISPOSABLE ANESTHESIA BREATHING CIRCUITSpecialty Packaging Producs, Inc.1991-05-08650

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