FDA product code LHX: Trousers, Anti-Shock
LHX is the FDA product code for trousers, anti-shock. It is a Class II device, regulated under 21 CFR 870.5800 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under LHX, from 4 different applicants. The average 510(k) review took 78 days (median 80). FDA has posted 1 recall for LHX devices.
Classification
| Field | Value |
|---|---|
| Device name | Trousers, Anti-Shock |
| Device class | Class II |
| Regulation | 21 CFR 870.5800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LHX clearance
Top LHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Jobst Institute, Inc. | 1 | 1995-11-28 |
| Vinyl Technology, Inc. | 1 | 1988-02-08 |
| Bp Medical Systems, Inc. | 1 | 1984-07-06 |
| Zee Medical Products Co., Inc. | 1 | 1981-10-23 |
Most recent LHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953763 | Jobst Institute, Inc. | GLADIATOR ANTISHOCK PANTS | 1995-11-28 | 109 |
| K874774 | Vinyl Technology, Inc. | TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS | 1988-02-08 | 81 |
| K841605 | Bp Medical Systems, Inc. | BP TRAUMA AIR PANTS | 1984-07-06 | 78 |
| K812564 | Zee Medical Products Co., Inc. | ZEE LIFE SUPPORT AIR PANTS | 1981-10-23 | 45 |
Recalls for LHX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-01-18.
Frequently asked questions
What is FDA product code LHX?
LHX is the FDA product code for trousers, anti-shock. It is a Class II device, regulated under 21 CFR 870.5800 and reviewed by the Cardiovascular panel.
What device class is LHX?
Class II, regulation 21 CFR 870.5800. Typical premarket route: 510(k).
How long does a 510(k) take for product code LHX?
Across 4 cleared submissions the average was 78 days from receipt to decision (median 80).
Which companies have the most LHX clearances?
Jobst Institute, Inc. (1); Vinyl Technology, Inc. (1); Bp Medical Systems, Inc. (1); Zee Medical Products Co., Inc. (1).
Have LHX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-01-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LHX
- Run a recall and safety report across every LHX manufacturer
- Watch product code LHX 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.
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