FDA product code HCS: Device, Temperature Measurement, Direct Contact, Powered
HCS is the FDA product code for device, temperature measurement, direct contact, powered. It is a Class II device, regulated under 21 CFR 882.1570 and reviewed by the Neurology panel. FDA has cleared 8 510(k) submissions under HCS, from 7 different applicants. The average 510(k) review took 80 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Device, Temperature Measurement, Direct Contact, Powered |
| Device class | Class II |
| Regulation | 21 CFR 882.1570 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HCS clearance
Top HCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gabriel Ent. | 2 | 1983-08-08 |
| Pos Technologies, Inc. | 1 | 1998-08-07 |
| Titronics Research & Development Co. | 1 | 1998-02-03 |
| Artronics | 1 | 1995-11-09 |
| Medtech Instruments | 1 | 1989-10-03 |
2 more applicants have HCS clearances. See the full list in Caduvo.
Most recent HCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981805 | Pos Technologies, Inc. | POS T-7000 | 1998-08-07 | 78 |
| K974208 | Titronics Research & Development Co. | TYTRON C-3000 | 1998-02-03 | 85 |
| K950986 | Artronics | NEUROREADER | 1995-11-09 | 251 |
| K894772 | Medtech Instruments | THERMALGRAPHIC ANALYSER | 1989-10-03 | 69 |
| K840487 | K.J. Electronics | T-METER | 1984-03-12 | 35 |
Recalls for HCS devices
openFDA lists no recalls for product code HCS.
Frequently asked questions
What is FDA product code HCS?
HCS is the FDA product code for device, temperature measurement, direct contact, powered. It is a Class II device, regulated under 21 CFR 882.1570 and reviewed by the Neurology panel.
What device class is HCS?
Class II, regulation 21 CFR 882.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCS?
Across 8 cleared submissions the average was 80 days from receipt to decision (median 62).
Which companies have the most HCS clearances?
Gabriel Ent. (2); Pos Technologies, Inc. (1); Titronics Research & Development Co. (1); Artronics (1); Medtech Instruments (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HCS
- Run a recall and safety report across every HCS manufacturer
- Watch product code HCS 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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