FDA product code FTY: Tape, Measuring, Rulers And Calipers
FTY is the FDA product code for tape, measuring, rulers and calipers. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 23 510(k) submissions under FTY, from 21 different applicants. The average 510(k) review took 40 days (median 31). FDA has posted 5 recalls for FTY devices.
Classification
| Field | Value |
|---|---|
| Device name | Tape, Measuring, Rulers And Calipers |
| 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 FTY clearance
Top FTY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympic Medical Corp. | 2 | 1993-12-29 |
| Professional Services For Surgeons, Ltd. | 2 | 1986-07-15 |
| Noxilizer, Inc. | 1 | 2016-05-26 |
| S-E Sales & Distribution, Inc. | 1 | 1995-05-19 |
| Stryker Corp. | 1 | 1988-09-13 |
16 more applicants have FTY clearances. See the full list in Caduvo.
Most recent FTY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160501 | Noxilizer, Inc. | Noxilizer Surgical Ruler | 2016-05-26 | 93 |
| K951064 | S-E Sales & Distribution, Inc. | DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC | 1995-05-19 | 72 |
| K934930 | Olympic Medical Corp. | OLYMPIC AUTO-LENGTH | 1993-12-29 | 76 |
| K932112 | Olympic Medical Corp. | OLYMPIC INFA-LENGTH | 1993-07-22 | 80 |
| K883485 | Stryker Corp. | STRYKER PRESSURE MONITOR SYSTEM | 1988-09-13 | 28 |
Recalls for FTY devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-03-05.
Frequently asked questions
What is FDA product code FTY?
FTY is the FDA product code for tape, measuring, rulers and calipers. 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 FTY?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FTY?
Across 23 cleared submissions the average was 40 days from receipt to decision (median 31).
Which companies have the most FTY clearances?
Olympic Medical Corp. (2); Professional Services For Surgeons, Ltd. (2); Noxilizer, Inc. (1); S-E Sales & Distribution, Inc. (1); Stryker Corp. (1).
Have FTY devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2015-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code FTY
- Run a recall and safety report across every FTY manufacturer
- Watch product code FTY 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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