Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Johnson & Johnson Professionals, Inc. — Predicate Candidate Screening
206 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
176 days90th percentile
206clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | Johnson & Johnson Professionals, Inc. | 2000-04-07 | 284 | 0 |
| K991413 | CODMAN ETHISORB DURA PATCH | Johnson & Johnson Professionals, Inc. | 2000-03-13 | 325 | 0 |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Johnson & Johnson Professionals, Inc. | 1999-07-09 | 88 | 0 |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Johnson & Johnson Professionals, Inc. | 1998-12-18 | 163 | 0 |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Johnson & Johnson Professionals, Inc. | 1998-12-04 | 115 | 0 |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Johnson & Johnson Professionals, Inc. | 1998-11-06 | 59 | 0 |
| K983014 | SUMMIT ACETABULAR SYSTEM | Johnson & Johnson Professionals, Inc. | 1998-10-27 | 60 | 0 |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | Johnson & Johnson Professionals, Inc. | 1998-07-17 | 137 | 0 |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Johnson & Johnson Professionals, Inc. | 1998-07-01 | 194 | 0 |
| K980801 | J-FX BIPOLAR HEAD | Johnson & Johnson Professionals, Inc. | 1998-05-29 | 88 | 0 |
| K980081 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD | Johnson & Johnson Professionals, Inc. | 1998-04-09 | 90 | 0 |
| K980286 | ULTIMA ACETABULAR ROOF REINFORCEMENT RING | Johnson & Johnson Professionals, Inc. | 1998-04-03 | 67 | 0 |
| K974331 | UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM | Johnson & Johnson Professionals, Inc. | 1998-02-06 | 80 | 0 |
| K974088 | CODMAN INTRACRANIAL BOLT | Johnson & Johnson Professionals, Inc. | 1998-01-09 | 71 | 1 |
| K973774 | CODMAN HAKIM MICRO PRECISION VALVE | Johnson & Johnson Professionals, Inc. | 1997-12-29 | 87 | 0 |
| K973307 | S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD | Johnson & Johnson Professionals, Inc. | 1997-11-20 | 78 | 0 |
| K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM | Johnson & Johnson Professionals, Inc. | 1997-09-11 | 73 | 9 |
| K971189 | P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) | Johnson & Johnson Professionals, Inc. | 1997-07-17 | 107 | 0 |
| K971652 | P.F.C. SIGMA INSET PATELLA | Johnson & Johnson Professionals, Inc. | 1997-07-16 | 71 | 0 |
| K971682 | J-FX CERCLAGE SYSTEM | Johnson & Johnson Professionals, Inc. | 1997-06-27 | 52 | 0 |
| K964923 | CODMAN LUMBAR DRAINAGE CATHETER KIT | Johnson & Johnson Professionals, Inc. | 1997-06-25 | 198 | 0 |
| K964795 | CEMENTED CALCAR REPLACEMENT FEMORAL STEM | Johnson & Johnson Professionals, Inc. | 1997-02-19 | 82 | 0 |
| K965156 | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES | Johnson & Johnson Professionals, Inc. | 1997-01-24 | 32 | 0 |
| K963885 | ULTIMA FX FEMORAL HIP STEMS | Johnson & Johnson Professionals, Inc. | 1996-12-09 | 74 | 0 |
| K963117 | P.F.C. CRUCIATE RETAING KNEE SYSTEM | Johnson & Johnson Professionals, Inc. | 1996-11-06 | 86 | 5 |
| K963206 | S-ROM HIP SYSTEM - LOCKING PLUG | Johnson & Johnson Professionals, Inc. | 1996-10-17 | 62 | 0 |
| K954481 | P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM | Johnson & Johnson Professionals, Inc. | 1996-10-10 | 379 | 0 |
| K963499 | MIRROR FINISH BIPOLAR FORCEPS | Johnson & Johnson Professionals, Inc. | 1996-10-08 | 35 | 0 |
| K962429 | SAFETY VEST | Johnson & Johnson Professionals, Inc. | 1996-09-18 | 86 | 0 |
| K962248 | P.F.C. CERAMIC HIP HEAD | Johnson & Johnson Professionals, Inc. | 1996-08-29 | 79 | 0 |
| K961939 | S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115 | Johnson & Johnson Professionals, Inc. | 1996-08-13 | 85 | 0 |
| K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) | Johnson & Johnson Professionals, Inc. | 1996-07-10 | 70 | 7 |
| K945518 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMP | Johnson & Johnson Professionals, Inc. | 1996-03-08 | 485 | 0 |
| K953202 | P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT | Johnson & Johnson Professionals, Inc. | 1996-01-31 | 205 | 0 |
| K952859 | ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT | Johnson & Johnson Professionals, Inc. | 1996-01-31 | 223 | 0 |
| K953200 | ULTIMA SIZE 0 CEMENTED FEMORAL STEM | Johnson & Johnson Professionals, Inc. | 1996-01-31 | 205 | 0 |
| K955385 | JOHNSON & JOHNSON AUSTIN MOORE STEM | Johnson & Johnson Professionals, Inc. | 1996-01-30 | 67 | 0 |
| K944544 | ABSORBABLE BONE SCREW | Johnson & Johnson Professionals, Inc. | 1996-01-26 | 498 | 0 |
| K952830 | DARWIN KNEE SYSTEM (TC3) | Johnson & Johnson Professionals, Inc. | 1996-01-18 | 212 | 7 |
| K954699 | BRAY RONGEUR | Johnson & Johnson Professionals, Inc. | 1995-12-06 | 55 | 0 |
| K954851 | BIOPOLAR FORCEPS LINE | Johnson & Johnson Professionals, Inc. | 1995-11-14 | 22 | 0 |
| K953730 | CODMAN ANTERIOR CERVICAL PLATE SYSTEM | Johnson & Johnson Professionals, Inc. | 1995-11-09 | 91 | 0 |
| K945585 | COMAN(R) CU-11 MODEL NUMBER 82-6634 | Johnson & Johnson Professionals, Inc. | 1995-10-26 | 346 | 0 |
| K954021 | EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) | Johnson & Johnson Professionals, Inc. | 1995-10-24 | 85 | 1 |
| K944222 | CODMAN-MEDOS VALVE SHUNT SYSTEM | Johnson & Johnson Professionals, Inc. | 1995-07-28 | 332 | 0 |
| K952161 | BIPOLAR COAGULATION INSTRUMENT | Johnson & Johnson Professionals, Inc. | 1995-07-05 | 58 | 0 |
| K950563 | ULTIMA AUGMENTED UHMWPE CUP | Johnson & Johnson Professionals, Inc. | 1995-06-07 | 119 | 0 |
| K951934 | PFC CEMENT RESTRICTOR | Johnson & Johnson Professionals, Inc. | 1995-05-16 | 21 | 0 |
| K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND | Johnson & Johnson Professionals, Inc. | 1995-05-15 | 132 | 16 |
| K945793 | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR | Johnson & Johnson Professionals, Inc. | 1995-04-10 | 136 | 0 |
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