FDA product code HTJ: Gauge, Depth
HTJ is the FDA product code for gauge, depth. It is a Class I device, regulated under 21 CFR 888.4300 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under HTJ, from 3 different applicants. The average 510(k) review took 40 days (median 38). FDA has posted 3 recalls for HTJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Gauge, Depth |
| Device class | Class I |
| Regulation | 21 CFR 888.4300 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HTJ clearance
Top HTJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acufex Microsurgical, Inc. | 2 | 1994-03-23 |
| Buckman Co., Inc. | 1 | 1987-09-09 |
| Cedar Surgical, Inc. | 1 | 1986-11-26 |
Most recent HTJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940480 | Acufex Microsurgical, Inc. | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE | 1994-03-23 | 49 |
| K925335 | Acufex Microsurgical, Inc. | ACUFEX INTRA ARTICULAR MEASURING DEVICE | 1992-12-29 | 68 |
| K873191 | Buckman Co., Inc. | ACROMED INTERBODY DEPTH GAUGES | 1987-09-09 | 27 |
| K864426 | Cedar Surgical, Inc. | RAYLOR(TM) DEPTH GAUGE | 1986-11-26 | 16 |
Recalls for HTJ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-05-28.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code HTJ?
HTJ is the FDA product code for gauge, depth. It is a Class I device, regulated under 21 CFR 888.4300 and reviewed by the Orthopedic panel.
What device class is HTJ?
Class I, regulation 21 CFR 888.4300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTJ?
Across 4 cleared submissions the average was 40 days from receipt to decision (median 38).
Which companies have the most HTJ clearances?
Acufex Microsurgical, Inc. (2); Buckman Co., Inc. (1); Cedar Surgical, Inc. (1).
Have HTJ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2019-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code HTJ
- Run a recall and safety report across every HTJ manufacturer
- Watch product code HTJ 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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