Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BXB — Predicate Candidate Screening
160 FDA 510(k) clearances under this product code; the 50 most recent screened below.
74 daysmedian FDA review time
307 days90th percentile
160clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072887 | G-TRAINER MEDICAL | Alter-G, Inc. | 2008-01-25 | 107 | 1 |
| K003272 | FLO-BOOT | Discovery Group, LLC | 2001-04-04 | 168 | 0 |
| K952975 | ANKLE CALF EXERCISER PHLEBOPUMP | Prevent Products, Inc. | 1996-09-25 | 456 | 0 |
| K953456 | E-Z FLEX | Fluid Motion Biotechnologies, Inc. | 1996-01-26 | 191 | 0 |
| K955106 | BTE CPM-20 | Baltimore Therapeutic Equipment Co. | 1995-12-29 | 51 | 0 |
| K955105 | BTE CPM-10 | Baltimore Therapeutic Equipment Co. | 1995-12-29 | 51 | 0 |
| K951028 | HAMEX TWO | Northern Orthopaedic Products, Inc. | 1995-12-11 | 279 | 0 |
| K950755 | FLEXMATE K500 | Breg, Inc. | 1995-10-05 | 230 | 0 |
| K951029 | HAMEX ONE | Northern Orthopaedic Products, Inc. | 1995-09-15 | 192 | 0 |
| K945733 | AQUAHAB, MODEL 120-72-101 | Aquarius Electronics, Inc. | 1995-09-15 | 296 | 0 |
| K950682 | W2 WRIST CPM UNIT | Toronto Medical Corp. | 1995-09-13 | 211 | 0 |
| K952369 | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE | Physicians Consulting, Inc. | 1995-08-07 | 98 | 0 |
| K945690 | BACKCYCLER CPM(TM) | Ergomedics, Inc. | 1995-06-22 | 213 | 0 |
| K946169 | ACTIC 2002 | North Atlantic Rehabilitation, Inc. | 1995-06-15 | 178 | 0 |
| K945824 | GALAXY MD SERIES THERAPYPOOLS | Galaxy Aquatics, Inc. | 1995-04-05 | 127 | 0 |
| K944819 | KRDL 2000 | Physicians Consulting, Inc. | 1995-03-10 | 162 | 0 |
| K945221 | SUTTER MODEL 6000 HAND CPM DEVICE | Sutter Corp. | 1995-02-27 | 124 | 0 |
| K945121 | A3 ANKLE CPM UNIT | Toronto Medical, Inc. | 1995-02-17 | 121 | 0 |
| K940455 | LATERAL FLEXION MACHINE | Rehab, Inc. | 1995-01-12 | 345 | 0 |
| K935011 | SWIMEX MULTIDEPTH POOL (MODEL 600T) | Swimex Systems | 1995-01-09 | 446 | 0 |
| K935587 | MULTILINK SHOULDER CPM UNIT | Toronto Medical Corp. | 1994-12-14 | 393 | 0 |
| K935509 | HYDROTRACK | Ferno Ille | 1994-10-03 | 322 | 0 |
| K935061 | LOWER BODY CYCLES | Biodex Medical Systems, Inc. | 1994-09-16 | 330 | 0 |
| K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) | Biodex Medical Systems, Inc. | 1994-09-16 | 302 | 0 |
| K935216 | SEMI-RECUMBENT CYCLES | Biodex Medical Systems, Inc. | 1994-09-16 | 325 | 0 |
| K942618 | ANKLE CALF EXERCISER | Prevent Products, Inc. | 1994-06-22 | 64 | 0 |
| K933059 | ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. | Jace Systems, Inc. | 1994-06-22 | 365 | 0 |
| K926136 | WATSYSTEM | Watsystem Div. of Itc | 1994-05-20 | 529 | 0 |
| K931128 | BASIC SHOULDER CPM | Danninger Medical Technology, Inc. | 1994-05-06 | 427 | 0 |
| K935467 | R & D BATTERIES, INC. PART NUMBER 5447 | R & D Batteries, Inc. | 1994-04-19 | 169 | 0 |
| K935188 | STRETCHPOWER | Orthopedic Development, Inc. | 1994-03-24 | 149 | 0 |
| K934175 | STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER | Orthopedic Development, Inc. | 1994-03-24 | 210 | 0 |
| K935808 | REVOLUTION LOWER LIMB CPM UNIT | Toronto Medical, Inc. | 1994-03-18 | 106 | 0 |
| K933394 | DANNIFLEX CPM 600 | Danninger Medical Technology, Inc. | 1994-03-11 | 242 | 0 |
| K930780 | ADV400 TOE CPM | Advanced Kinetics, Inc. | 1994-02-17 | 366 | 0 |
| K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS | Henley Intl. | 1994-02-04 | 416 | 0 |
| K931555 | ARTROMOT K2 CPM | Ormed Mfg., Inc. | 1994-01-31 | 307 | 0 |
| K931736 | M-FLEX 5000 C3PMD | Medical Systems Corp. | 1994-01-27 | 295 | 0 |
| K931723 | HYDRO-TRED/AIR POWERED TREADMILL | Santa FE Swim Systems | 1994-01-26 | 310 | 0 |
| K926262 | FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE | Sgarlato Laboratories, Inc. | 1994-01-26 | 404 | 0 |
| K933311 | MOTORIZED ELECTRIC PARALLEL BARS | Midland Mfg. Co. | 1994-01-26 | 203 | 0 |
| K925270 | EX N' FLEX EF-200 | Tecogics Scientific , Ltd. | 1993-07-21 | 275 | 0 |
| K924513 | LIDO(R) LINEA | Loredan Biomedical, Inc. | 1993-03-31 | 208 | 0 |
| K925271 | REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE | Repex Intl., Inc. | 1993-03-31 | 163 | 0 |
| K925977 | PARAMED FLEXION-EXTENSION MACHINE | Paramed Services, Inc. | 1993-03-31 | 126 | 0 |
| K925807 | AQUACISER IN-POOL TREADMILL | Aquaciser, Inc. | 1993-03-24 | 128 | 0 |
| K925926 | MOBILIMB T1 TOE CPM UNIT | Toronto Medical Corp. | 1993-03-22 | 119 | 0 |
| K924484 | ARTROMOT MULTI DIRECTIONAL ANKLE CPM | Buckman Co., Inc. | 1993-03-22 | 200 | 0 |
| K925666 | THERAPACER 3000 | Kvm Technologies, Inc. | 1993-03-09 | 119 | 0 |
| K924654 | FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT | Sutter Corp. | 1993-02-22 | 160 | 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