FDA product code HRQ: Hemostat
HRQ is the FDA product code for hemostat. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 15 510(k) submissions under HRQ, from 12 different applicants. The average 510(k) review took 44 days (median 33). FDA has posted 3 recalls for HRQ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Hemostat |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HRQ clearance
Top HRQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scanlan Intl., Inc. | 3 | 1984-06-05 |
| I M, Inc. | 2 | 1984-11-07 |
| Falcon Instruments, Inc. | 1 | 1992-08-11 |
| Applied Medical Technologies | 1 | 1989-10-24 |
| Kinetic Medical Products | 1 | 1989-01-27 |
7 more applicants have HRQ clearances. See the full list in Caduvo.
Most recent HRQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920298 | Falcon Instruments, Inc. | DISPOSABLE HEMOSTATS | 1992-08-11 | 202 |
| K895683 | Applied Medical Technologies | BERNARD VESSEL APPROXIMATOR | 1989-10-24 | 33 |
| K890245 | Kinetic Medical Products | SURGICAL HEMOSTATS | 1989-01-27 | 9 |
| K884196 | Disposable Sterile Surgical Instruments, Inc. | SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) | 1988-11-08 | 35 |
| K881937 | Far East Intl. Trading Corp. | SURGICAL INSTRUMENTS | 1988-06-15 | 37 |
Recalls for HRQ devices
3 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-01-31.
| Year | Recalls |
|---|---|
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code HRQ?
HRQ is the FDA product code for hemostat. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is HRQ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRQ?
Across 15 cleared submissions the average was 44 days from receipt to decision (median 33).
Which companies have the most HRQ clearances?
Scanlan Intl., Inc. (3); I M, Inc. (2); Falcon Instruments, Inc. (1); Applied Medical Technologies (1); Kinetic Medical Products (1).
Have HRQ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code HRQ
- Run a recall and safety report across every HRQ manufacturer
- Watch product code HRQ 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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