FDA product code FTZ: Locator, Magnetic
FTZ is the FDA product code for locator, magnetic. It is a Class I device, regulated under 21 CFR 886.4445 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under FTZ, from 2 different applicants. The average 510(k) review took 106 days (median 106).
Classification
| Field | Value |
|---|---|
| Device name | Locator, Magnetic |
| Device class | Class I |
| Regulation | 21 CFR 886.4445 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Top FTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| H & M Douglas Enterprises, Inc. | 1 | 1984-01-27 |
| Western Laboratories Corp. | 1 | 1983-04-12 |
Most recent FTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833229 | H & M Douglas Enterprises, Inc. | SUN BED BY VERRE ET QUARTZ UVA-FRANCE | 1984-01-27 | 156 |
| K830468 | Western Laboratories Corp. | MODEL 200 | 1983-04-12 | 56 |
Recalls for FTZ devices
openFDA lists no recalls for product code FTZ.
Frequently asked questions
What is FDA product code FTZ?
FTZ is the FDA product code for locator, magnetic. It is a Class I device, regulated under 21 CFR 886.4445 and reviewed by the Ophthalmic panel.
What device class is FTZ?
Class I, regulation 21 CFR 886.4445. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FTZ?
Across 2 cleared submissions the average was 106 days from receipt to decision (median 106).
Which companies have the most FTZ clearances?
H & M Douglas Enterprises, Inc. (1); Western Laboratories Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FTZ
- Run a recall and safety report across every FTZ manufacturer
- Watch product code FTZ 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.