FDA product code KTZ: Caliper
KTZ is the FDA product code for caliper. It is a Class I device, regulated under 21 CFR 888.4150 and reviewed by the Orthopedic panel. FDA has cleared 7 510(k) submissions under KTZ, from 7 different applicants. The average 510(k) review took 50 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Caliper |
| Device class | Class I |
| Regulation | 21 CFR 888.4150 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KTZ clearance
Top KTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nk Biotechnical Engineering Co. | 1 | 1992-07-14 |
| Caldwell, Justiss & Co., Inc. | 1 | 1984-06-28 |
| Dr. Micheal A. Sabia | 1 | 1983-07-19 |
| Twin City Surgical, Inc. | 1 | 1982-03-19 |
| Fitness Motivation Institute of America | 1 | 1981-02-04 |
2 more applicants have KTZ clearances. See the full list in Caduvo.
Most recent KTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K921266 | Nk Biotechnical Engineering Co. | NK MEDICAL MICROMETER, MODEL MC001 | 1992-07-14 | 120 |
| K841687 | Caldwell, Justiss & Co., Inc. | SKYNDEX ELECTRONIC BODY FAT CALCULA | 1984-06-28 | 66 |
| K831898 | Dr. Micheal A. Sabia | SCOLIMETER | 1983-07-19 | 35 |
| K820659 | Twin City Surgical, Inc. | A CALIPER | 1982-03-19 | 9 |
| K810116 | Fitness Motivation Institute of America | ISOROBIC SKINFOLD CALIPER | 1981-02-04 | 20 |
Recalls for KTZ devices
openFDA lists no recalls for product code KTZ.
Frequently asked questions
What is FDA product code KTZ?
KTZ is the FDA product code for caliper. It is a Class I device, regulated under 21 CFR 888.4150 and reviewed by the Orthopedic panel.
What device class is KTZ?
Class I, regulation 21 CFR 888.4150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTZ?
Across 7 cleared submissions the average was 50 days from receipt to decision (median 35).
Which companies have the most KTZ clearances?
Nk Biotechnical Engineering Co. (1); Caldwell, Justiss & Co., Inc. (1); Dr. Micheal A. Sabia (1); Twin City Surgical, Inc. (1); Fitness Motivation Institute of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTZ
- Run a recall and safety report across every KTZ manufacturer
- Watch product code KTZ 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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