Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FWZ — Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
26 daysmedian FDA review time
77 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960019 | RETRACTOR ARM CLAMP | Biopsys Medical, Inc. | 1996-02-09 | 38 | 0 |
| K945415 | 'LIL MAC ACCESSORY CLAMP(TM) | D.L. Nelson and Assoc., Inc. | 1994-11-22 | 15 | 0 |
| K944779 | CARBON LIGHTS HAND SURGERY TABLE | Allen Medical Systems, Inc. | 1994-10-14 | 17 | 0 |
| K935381 | KAPS POSITIONING ARM | Andronic Devices, Ltd. | 1994-04-15 | 158 | 0 |
| K931037 | WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) | Whitmore Ent., Inc. | 1993-07-30 | 151 | 0 |
| K926225 | SPONGE COUNTER | American Medical Manufacturer, Inc. | 1993-03-05 | 85 | 0 |
| K925035 | MIDKIFF GEOSTATIC CLAMP | D.L. Nelson and Assoc., Inc. | 1993-02-18 | 136 | 0 |
| K905564 | PREP AND OPERATING STAND | Mcconnell Orthopedic | 1991-02-21 | 71 | 0 |
| K905565 | LATERAL BUTTRESS SUPPORT | Mcconnell Orthopedic | 1991-02-21 | 71 | 0 |
| K910031 | PARK CITY SHOULDER POSITIONER | Orthopedic Systems, Inc. | 1991-01-24 | 20 | 0 |
| K904826 | TKO TELESCOPING LITHOTOMY STIRRUP | D.L. Nelson and Assoc., Inc. | 1990-10-31 | 6 | 0 |
| K897028 | LINCOLN MILLS FOOT AND LEG HOLDER | Lincoln Mills, Inc. | 1990-01-12 | 24 | 0 |
| K893969 | DECUBITUS CARE PAD | Gulftrade Exim, Inc. | 1989-07-14 | 42 | 0 |
| K890501 | SECOND ASSISTANT | 3M Company | 1989-02-10 | 9 | 0 |
| K885215 | LINCOLN MILLS HIP HOLDER | Lincoln Mills, Inc. | 1989-01-13 | 25 | 0 |
| K884928 | FREE ARM(TM) | Faro Medical Technologies, Inc. | 1988-12-15 | 17 | 0 |
| K882078 | SPINAL SURGERY FRAME | Karlin Technology, Inc. | 1988-06-16 | 30 | 0 |
| K880265 | WEHBE ARM HOLDER | Orthopedic Systems, Inc. | 1988-02-18 | 27 | 0 |
| K873139 | VARUS AND VALGUS LEG HOLDER | Leonard Medical, Inc. | 1987-09-16 | 37 | 0 |
| K873370 | ALLEN MALLEABLE ANESTHESIA SCREEN | Edgewater Medical Equipment Systems | 1987-09-11 | 21 | 0 |
| K872900 | THE PORTABLE ORDERLY | Edgewater Medical Equipment Systems | 1987-08-21 | 28 | 0 |
| K871823 | MCCONNELL ORTHOPEDIC TIBIAL POSITIONER | Mcconnell Orthopedic | 1987-05-26 | 15 | 0 |
| K871820 | MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT | Mcconnell Orthopedic | 1987-05-26 | 15 | 0 |
| K871822 | MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY | Mcconnell Orthopedic | 1987-05-26 | 15 | 0 |
| K871821 | MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT | Mcconnell Orthopedic | 1987-05-26 | 15 | 0 |
| K871824 | MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM | Mcconnell Orthopedic | 1987-05-26 | 15 | 0 |
| K871839 | MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT | Mcconnell Orthopedic | 1987-05-26 | 14 | 0 |
| K871840 | MCCONNELL ORTHOPEDIC ANKLE POSITIONER | Mcconnell Orthopedic | 1987-05-26 | 14 | 0 |
| K871819 | MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER | Mcconnell Orthopedic | 1987-05-22 | 11 | 0 |
| K871703 | MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM | Mcconnell Orthopedic | 1987-05-19 | 18 | 0 |
| K871803 | MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP) | Mcconnell Orthopedic | 1987-05-19 | 11 | 0 |
| K871805 | MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT | Mcconnell Orthopedic | 1987-05-19 | 11 | 0 |
| K871804 | MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY | Mcconnell Orthopedic | 1987-05-19 | 11 | 0 |
| K871225 | HAND SURGERY TABLE EXTENSION | Orthopedic Systems, Inc. | 1987-04-07 | 11 | 0 |
| K870101 | CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K870098 | LITHOTOMY HOLDERS | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K870104 | RADIOLUCENT TABLE EXTENSION | Orthopedic Systems, Inc. | 1987-02-06 | 28 | 0 |
| K865024 | ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER | American Container Technology, Inc. | 1987-01-12 | 20 | 0 |
| K864880 | COLLINS POSITIONING DEVICE | Orthopedic Systems, Inc. | 1986-12-29 | 17 | 0 |
| K864881 | ARTHROSCOPIC ANKLE HOLDER | Orthopedic Systems, Inc. | 1986-12-29 | 17 | 0 |
| K864459 | RAIL CLAMP EXTENSION PIECE | American Container Technology, Inc. | 1986-12-01 | 19 | 0 |
| K860446 | C ARM SURGICAL TABLE | Medi-Mech, Inc. | 1986-03-10 | 34 | 0 |
| K842700 | BASILDON-GARDNER SPINAL FRAME | Downs Surgical , Ltd. | 1984-09-12 | 63 | 0 |
| K840684 | FPP ARMBOARD STRAP | Fpp, Inc. | 1984-04-23 | 68 | 0 |
| K840422 | DEVON HEAD REST | Devon Industries, Inc. | 1984-03-12 | 41 | 0 |
| K840421 | ULNAR NERVE PROTECTOR | Devon Industries, Inc. | 1984-03-12 | 41 | 0 |
| K833624 | SHUTT UNIVERSAL STRESS POST | Concept, Inc. | 1983-11-28 | 45 | 0 |
| K832472 | ELEVATOR CUSHION | Inmed Corp. | 1983-09-20 | 56 | 0 |
| K830272 | PROTET HOLDERS-BLOCKS & ROLL | Ritmed, Inc. | 1983-06-03 | 129 | 0 |
| K830707 | ACUFEX UNIVERSAL LEG HOLDER | Acufex Microsurgical, Inc. | 1983-05-02 | 56 | 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