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

Packaging Technologies, Inc. — Predicate Candidate Screening

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

37 daysmedian FDA review time
95 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K881756STERILE SURGEONS GLOVESPackaging Technologies, Inc.1988-06-01370
K863326BONE MARROW TRAYPackaging Technologies, Inc.1986-09-16200
K861041ENHANCEPackaging Technologies, Inc.1986-05-30730
K850544SHAVE PREP TRAYPackaging Technologies, Inc.1985-03-12280
K850438RENAL BIOPSY TRAYPackaging Technologies, Inc.1985-02-26210
K844613GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TRPackaging Technologies, Inc.1985-01-10440
K844611SINGLE BASIN SETPackaging Technologies, Inc.1984-12-19220
K844614IV START KITPackaging Technologies, Inc.1984-12-19220
K844612ACUTE HEMODIALYSIS TRAYSPackaging Technologies, Inc.1984-12-17200
K834074PERCUTANEOUS SHEATH INTRODUCER TRAYPackaging Technologies, Inc.1984-03-191150
K834073CENTRAL VEIN CATHERIZATION TRAY CC-20Packaging Technologies, Inc.1984-02-28950
K833758P.T.I. DRESSING CHANGE TRAYSPackaging Technologies, Inc.1984-01-26920
K832880TRACHEOSTOMY CARE TRAYSPackaging Technologies, Inc.1983-10-31660

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