Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ITH — Predicate Candidate Screening
71 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
245 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025-07-18 | 221 | 0 |
| K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | 2025-06-18 | 233 | 0 |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024-02-22 | 791 | 0 |
| K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023-05-16 | 232 | 0 |
| K151640 | ELTRAC 471 | Enraf-Nonius, B.V. | 2015-10-16 | 120 | 0 |
| K150695 | Modpod | Hollywog, LLC | 2015-08-13 | 148 | 0 |
| K131983 | ITRAC CERVICAL TRACTION SYSTEM | Pivotal Health Solutions | 2014-09-10 | 439 | 0 |
| K130249 | INTEGRITY SPINAL CARE SYSTEM 3.0 | Integrity Life Sciences | 2014-02-06 | 370 | 0 |
| K112074 | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | Everyway Medical Instruments Co.,Ltd | 2012-02-01 | 196 | 0 |
| K103248 | INTEGRITY SPINAL CARE SYSTEM | Integra Life Sciences | 2011-04-05 | 153 | 0 |
| K101889 | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | Pivotal Health Solutions | 2010-08-27 | 51 | 1 |
| K091540 | MTD 4000 | Mettler Electronics Corp. | 2009-10-08 | 135 | 1 |
| K081247 | TM-400 | Ito Co., Ltd. | 2008-08-25 | 116 | 0 |
| K072064 | GRAVILAX TRACTION SYSTEM | Therapeutic Clinical Technologies, Inc. | 2008-04-21 | 269 | 0 |
| K073132 | MODEL D DISC FORCE | North American Medical Corp (Nam) | 2008-04-03 | 148 | 0 |
| K073542 | CYCLETRAC CT-5000 | Pt Products, LLC | 2008-02-14 | 59 | 2 |
| K071347 | VAX-D GENESIS G2 SYSTEM | Vax-D Medical Technologies, LLC | 2007-10-05 | 144 | 0 |
| K063353 | CTBOX CERVICAL/LUMBAR TRACTION | Circular Traction Supply, Inc. | 2007-03-14 | 128 | 0 |
| K060735 | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM | Axiom Worldwide, Inc. | 2006-05-26 | 67 | 0 |
| K053223 | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | Chattanooga Group | 2006-02-24 | 99 | 0 |
| K052453 | TRACTION SYSTEM, DIGIT-TRAC 930 | Ever Prosperous Instrument, Inc. | 2006-01-13 | 128 | 0 |
| K053503 | VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) | Vax-D Medical Technologies USA, L.C. | 2005-12-28 | 12 | 0 |
| K051938 | TRITON/TRU-TRAC/TX TRACTION DEVICES | Chattanooga Group | 2005-09-21 | 65 | 0 |
| K033231 | SPINA SYSTEM | North American Medical Corp (Nam) | 2005-09-09 | 704 | 0 |
| K051013 | SPINEMED S200B/S200C | Cert Health Sciences, LLC | 2005-04-27 | 6 | 0 |
| K042482 | BASS ANTALGIC-TRAK | Traction Masters, LLC | 2005-03-21 | 189 | 0 |
| K043239 | HEALTHSTAR ELITE | Hill Laboratories Co. | 2004-12-22 | 29 | 0 |
| K031996 | EXTENTRAC ELITE | Advanced Back Technologies | 2004-07-23 | 392 | 2 |
| K031862 | SPINERX-LDM | Spinerx Technology | 2003-10-31 | 137 | 0 |
| K031227 | LORDEX POWER TRACTION EQUIPMENT | Ever Prosperous Instrument, Inc. | 2003-07-17 | 90 | 0 |
| K030060 | SPINEMED | Cert Health Sciences, LLC | 2003-02-05 | 29 | 0 |
| K022602 | DRX3000 | Axiom Usa., Inc. | 2003-01-23 | 170 | 0 |
| K023160 | DRX5000 | Axiom Usa., Inc. | 2002-12-20 | 88 | 0 |
| K010292 | DRX 2000 | Axiom Worldwide, Inc. | 2001-05-01 | 90 | 0 |
| K001712 | 3D ACTIVETRAC | The Saunders Group | 2000-08-31 | 87 | 0 |
| K002260 | SPINA SYSTEM | North American Medical Corporation (Nam) | 2000-08-25 | 31 | 0 |
| K001361 | JILCO TRACTION-FLEXION CHAIR | Jilco Enterprises | 2000-07-19 | 82 | 0 |
| K001296 | SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM | Cavendish Scott, Inc. | 2000-07-17 | 84 | 0 |
| K001401 | AMT THERAPEUTIC TABLE, MODEL 748AMT | Amt Mfg., Inc. | 2000-07-12 | 70 | 0 |
| K993919 | DYNATRON 900 | Dynatronics Corp. | 2000-01-03 | 46 | 0 |
| K991835 | HANG UPS POWER II | Stl Intl., Inc. | 1999-12-20 | 206 | 0 |
| K992733 | AKRON ATP9 TRACTION MACHINE | Huntleigh Technology, Inc. | 1999-11-10 | 89 | 0 |
| K992545 | TM-300 TRACTION SYSTEM | Ito Co., Ltd. | 1999-09-01 | 33 | 1 |
| K991931 | CTD MARK I TRACTION DEVICE | Therasys, Inc. | 1999-08-12 | 65 | 0 |
| K981822 | DRS SYSTEM | Professional Distribution Systems, Inc. | 1998-06-24 | 33 | 0 |
| K951622 | VAX-D THERAPEUTIC TABLE | Vat-Tech, Inc. | 1996-07-02 | 488 | 0 |
| K944699 | ATT-300 | Health Care Mfg., Inc. | 1995-05-26 | 245 | 0 |
| K951228 | ASH-7000 | U.S. Table, Inc. | 1995-05-17 | 58 | 0 |
| K940200 | EXCEL TX | Excel Tech. , Ltd. | 1994-06-07 | 145 | 0 |
| K940590 | MINTO SKIN TRACTION MOTOR | Minto Research & Development, Inc. | 1994-04-15 | 66 | 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