FDA product code HBT: Applier, Hemostatic Clip
HBT is the FDA product code for applier, hemostatic clip. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under HBT, from 4 different applicants. The average 510(k) review took 100 days (median 46). FDA has posted 14 recalls for HBT devices.
Classification
| Field | Value |
|---|---|
| Device name | Applier, Hemostatic Clip |
| 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 HBT clearance
Top HBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard-Allan Medical | 1 | 1993-07-21 |
| Richard-Allan Medical Ind., Inc. | 1 | 1990-01-02 |
| Downs Surgical , Ltd. | 1 | 1986-07-30 |
| Edward Weck, Inc. | 1 | 1980-03-10 |
Most recent HBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924929 | Richard-Allan Medical | REFLEX(R) ECA | 1993-07-21 | 294 |
| K896262 | Richard-Allan Medical Ind., Inc. | TITANIUM LIGATING CLIPS | 1990-01-02 | 64 |
| K862696 | Downs Surgical , Ltd. | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP | 1986-07-30 | 15 |
| K800318 | Edward Weck, Inc. | DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI | 1980-03-10 | 27 |
Recalls for HBT devices
14 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-19.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code HBT?
HBT is the FDA product code for applier, hemostatic clip. 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 HBT?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HBT?
Across 4 cleared submissions the average was 100 days from receipt to decision (median 46).
Which companies have the most HBT clearances?
Richard-Allan Medical (1); Richard-Allan Medical Ind., Inc. (1); Downs Surgical , Ltd. (1); Edward Weck, Inc. (1).
Have HBT devices been recalled?
Yes: 14 product recalls across 6 recall events; the most recent began 2018-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HBT
- Run a recall and safety report across every HBT manufacturer
- Watch product code HBT 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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