FDA product code HST: Apparatus, Traction, Non-Powered
HST is the FDA product code for apparatus, traction, non-powered. It is a Class I device, regulated under 21 CFR 888.5850 and reviewed by the Neurology panel. FDA has cleared 38 510(k) submissions under HST, from 27 different applicants. The average 510(k) review took 43 days (median 23). FDA has posted 11 recalls for HST devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Traction, Non-Powered |
| Device class | Class I |
| Regulation | 21 CFR 888.5850 |
| Review panel | NE — Neurology |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HST clearance
Top HST applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 8 | 1987-02-04 |
| Lossing Orthopedic, Inc. | 3 | 1986-08-07 |
| Comfortex, Inc. | 2 | 1986-01-21 |
| Biomet, Inc. | 2 | 1978-02-23 |
| Stl International, Inc. | 1 | 2016-12-30 |
22 more applicants have HST clearances. See the full list in Caduvo.
Most recent HST clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162702 | Stl International, Inc. | Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table | 2016-12-30 | 93 |
| K110858 | Roland F Berthiaume, DC | LO-BAK TRAX | 2011-08-02 | 127 |
| K984190 | Back-On-Track, Inc. | BACK-ON-TRAC, MODEL 101BOT | 1999-03-15 | 112 |
| K872121 | Joseph A. Kott, M.D. | K AND D HOME TRACT | 1987-08-12 | 77 |
| K870212 | Dyonics, Inc. | ARTHROSCOPIC SHOULDER HOLDER | 1987-02-20 | 31 |
Recalls for HST devices
11 product recalls in 11 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-03-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HST?
HST is the FDA product code for apparatus, traction, non-powered. It is a Class I device, regulated under 21 CFR 888.5850 and reviewed by the Neurology panel.
What device class is HST?
Class I, regulation 21 CFR 888.5850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HST?
Across 38 cleared submissions the average was 43 days from receipt to decision (median 23).
Which companies have the most HST clearances?
Orthopedic Systems, Inc. (8); Lossing Orthopedic, Inc. (3); Comfortex, Inc. (2); Biomet, Inc. (2); Stl International, Inc. (1).
Have HST devices been recalled?
Yes: 11 product recalls across 11 recall events; the most recent began 2024-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code HST
- Run a recall and safety report across every HST manufacturer
- Watch product code HST for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times