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

Thantex Specialties, Inc. — Predicate Candidate Screening

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

181 daysmedian FDA review time
304 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970547ISOLYSER SDS SHARPS CONTAINERThantex Specialties, Inc.1997-07-181560
K961083OREX SURGEON'S VESTThantex Specialties, Inc.1996-08-231570
K942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSThantex Specialties, Inc.1995-08-074590
K943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSThantex Specialties, Inc.1995-06-163250
K945755OREX(R) O.R EQUIPMENT DRAPESThantex Specialties, Inc.1995-05-251830
K945223OREX ISOLATION GOWNThantex Specialties, Inc.1995-04-251810
K944859OREX SURGICAL DRAPESThantex Specialties, Inc.1995-02-281480
K944827OREX SURGEON'S GOWNThantex Specialties, Inc.1995-02-281520
K943034OREX SHOE COVERSThantex Specialties, Inc.1995-01-021890
K942228OREX O.R. TOWELThantex Specialties, Inc.1994-12-202280
K940764OREXThantex Specialties, Inc.1994-12-193040
K940767OREX (12X12 X-RAY DETECTABLE)Thantex Specialties, Inc.1994-12-193040
K940765ISOLYSERThantex Specialties, Inc.1994-12-193040
K940766OREX (18X18 X-RAY DETECTABLE)Thantex Specialties, Inc.1994-12-193040
K940716OREXThantex Specialties, Inc.1994-12-193040
K944953OREX MEDICAL BEDDINGThantex Specialties, Inc.1994-12-02560
K940762ISOLYSER (18X18 X-RAY DETECTABLE)Thantex Specialties, Inc.1994-05-02730
K940763ISOLYSER (8X4 12 PLY X-RAY DETECTABLE)Thantex Specialties, Inc.1994-05-02730
K940756ISOLYSER (X-RAY DETECTABLE)Thantex Specialties, Inc.1994-05-02730
K940757ISOLYSER (4X18) X-RAY DETECTABLEThantex Specialties, Inc.1994-05-02730
K940754ISOLYER (4X4, 12 PLY)Thantex Specialties, Inc.1994-05-02730

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