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

Mallinckrodt Group, Inc. · Predicate Candidate Screening

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

97 daysmedian FDA review time
214 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945053LF CT HIG PRESSURE CATHETERSMallinckrodt Group, Inc.1995-05-192170
K945140URO-FLOMallinckrodt Group, Inc.1995-03-081390
K943581HYDRADJUST IV UROLOGICAL TABLEMallinckrodt Group, Inc.1995-01-041662
K943122SURGICAL DRAPESMallinckrodt Group, Inc.1994-09-07700
K934664HYDRAGOWNMallinckrodt Group, Inc.1994-05-242380
K920742HYDRAJUST IV UROLOGICAL TABLEMallinckrodt Group, Inc.1992-04-27681
K912944CT 8000 DIGITAL INJECTION SYSTEMMallinckrodt Group, Inc.1992-02-042141
K913264HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICEMallinckrodt Group, Inc.1991-11-011010
K905789FRANKLIN 9000 WALL STANDMallinckrodt Group, Inc.1991-05-201440
K904144PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEMMallinckrodt Group, Inc.1990-12-13970
K904147HUGH YOUNG II UROLOGICAL X-RAY SYSTEMMallinckrodt Group, Inc.1990-12-13970
K904146NEURO VISION RADIOGRAPHIC X-RAY SYSTEMMallinckrodt Group, Inc.1990-12-13970
K904145HYDRA VISION UROLOGICAL X-RAY SYSTEMMallinckrodt Group, Inc.1990-12-13970
K902761AUTOMATIC CASSETTE LOADERMallinckrodt Group, Inc.1990-10-091060
K902446DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUSTMallinckrodt Group, Inc.1990-08-10700
K902221MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGEMallinckrodt Group, Inc.1990-08-08830
K901323HYDRA VIEW IMAGING SYSTEMMallinckrodt Group, Inc.1990-04-25350
K891403HUGH YOUNG II UROLOGICAL TABLEMallinckrodt Group, Inc.1989-06-221000
K882329L-F COILED EXTENSION TUBINGMallinckrodt Group, Inc.1988-09-02881
K883312L-F/KODAK FLEXIBLE GRID CASSETTEMallinckrodt Group, Inc.1988-08-16110
K873687ANGIOMAT CT INJECTORMallinckrodt Group, Inc.1987-10-09250
K860204ANGIOMAT 6000Mallinckrodt Group, Inc.1986-05-021000
K860040HYDRAJUST III UROLOGICAL TABLEMallinckrodt Group, Inc.1986-02-10350
K781334DISPOSABLE SYRINGE FILL TUBEMallinckrodt Group, Inc.1978-08-17153
K770836ULTIMAT L4 X L4, LIEBEL-FLARSHEIMMallinckrodt Group, Inc.1977-05-26200
K760522TABLE, UROSURGICALMallinckrodt Group, Inc.1976-12-161120
K760279X-RAY FILM, CONVEY OR SYSTEMMallinckrodt Group, Inc.1976-08-13210

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