510(k) · Cleared
ClearedDRS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Professional Distribution Systems, Inc. · ITH Equipment, Traction, Powered
Cleared on Jun 24, 1998 as substantially equivalent to K844385 (Nor-Am Patient Care Products, Inc., 1985) and 1 other predicate after a 33-day review. Its family tree reaches back 2 generations to 1989. 16 later devices descend from it.
- Decided
- Jun 24, 1998
- Review
- 33 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K894435 (1989). 3 ancestors in all, the oldest K844385 (1985). 16 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 1 generation backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- This deviceK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- Descendant · cites it directly · 10 of its ownK030060 SpinemedCert Health Sciences, LLC · 2003
- Descendant · cites it directly · 9 of its ownK031862 Spinerx-LDMSpinerx Technology · 2003
- Descendant · 2 generations on · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- Descendant · cites it directly · 2 of its ownK992545 TM-300 Traction SystemIto Co., Ltd. · 1999 · Recalled
- Descendant · 3 generations on · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K030060SpinemedCert Health Sciences, LLC · 2003 · cites it directly10descendants
- K031862Spinerx-LDMSpinerx Technology · 2003 · cites it directly9descendants
- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · 2 generations on8descendants
- K992545TM-300 Traction SystemIto Co., Ltd. · 1999 · cites it directly2descendants
- K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −1 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| 0 (this device) | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| +1 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| +1 | K031862 | Spinerx-LDM | Spinerx Technology | 2003 | — |
| +2 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| +1 | K992545 | TM-300 Traction System | Ito Co., Ltd. | 1999 | 1 |
| +3 | K151640 | Eltrac 471 | Enraf-Nonius, B.V. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K844385 | Escotek Est Trac 401Summary page 1…, Inc. Tel: (561) 988-1747 / Fax (561) 988-9067 May 21, 1998 DRS System Traction Equipment Power Traction Equipment Class I1 (21 CFR Section 890.5900) 89ITH 870RS K844385 Tru-Trac 401 Traction - Henley International K951622 VAX-D® Therapeutic Table - Vat-Tech, Inc. Devi ription: The DRS System™ is… | 1985 |
| * | K951622 | Vax-D Therapeutic TableSummary page 1…21, 1998 DRS System Traction Equipment Power Traction Equipment Class I1 (21 CFR Section 890.5900) 89ITH 870RS K844385 Tru-Trac 401 Traction - Henley International K951622 VAX-D® Therapeutic Table - Vat-Tech, Inc. Devi ription: The DRS System™ is designed to apply distraction forces to a patient’s… | 1996 |
What descends from it? (16)
See all 168 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030060 (Cert Health Sciences, LLC, 2003) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K844385.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DRS System provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRS System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981822: DRS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981822
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026