510(k) · Cleared
ClearedHealthstar Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill Laboratories Co. · ITH Equipment, Traction, Powered
Cleared on Dec 22, 2004 as substantially equivalent to K981822 (Professional Distribution Systems, Inc., 1998) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Dec 22, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894435 (1989). 6 ancestors in all, the oldest K844385 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 3 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 2 generations backK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- 1 generation backK030060 SpinemedCert Health Sciences, LLC · 2003
- This deviceK043239 Healthstar EliteHill Laboratories Co. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −3 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −2 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| −1 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| 0 (this device) | K043239 | Healthstar Elite | Hill Laboratories Co. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K981822 | DRS SystemSummary page 1…DRS System Professional Distribution Systems, Inc. 510(k): K981822 SpineMED Cert Health Sciences, L… | 1998 |
| * | K030060 | SpinemedSummary page 1…SpineMED Cert Health Sciences, LLC 510(k): K030060 Description: The Healthstar Elite is a multifunction elevation traction table designed to apply distraction forces to a patie… | 2003 |
| * | K002260 | Spina SystemSummary page 2…ristics Healthstar Elite incorporates various principles and working characteristics of the predicate devices, SpineMED (K030060), DRS System (K981822) and SPINA System (K002260). The Healthstar Elite employs a unique method of restraining the patient's body to the table surface, which has not impacted on,… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- 7 other devices also cite its predicate K981822.
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 Healthstar Elite machine administers genuine intervertebral decompression. Each treatment session consists of a physician prescribed treatment period on the Healthstar Elite. A treatment is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. The machine can be used to relieve sciatica pain and pain associated with: bulging or herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
This device is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043239: Healthstar Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043239
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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