FTY
23 FDA 510(k) clearances · Product code
31 daysmedian time to decision
80 days90th percentile
23clearances measured
FDA profile
- Official device name
- Tape, Measuring, Rulers And Calipers
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2003: 1 · 2020: 112 · 2021: 161 · 2022: 93
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Noxilizer Surgical Ruler (K160501) | Noxilizer, Inc. | 2016-05-26 |
| DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC (K951064) | S-E Sales & Distribution, Inc. | 1995-05-19 |
| OLYMPIC AUTO-LENGTH (K934930) | Olympic Medical Corp. | 1993-12-29 |
| OLYMPIC INFA-LENGTH (K932112) | Olympic Medical Corp. | 1993-07-22 |
| STRYKER PRESSURE MONITOR SYSTEM (K883485) | Stryker Corp. | 1988-09-13 |
| PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. (K880441) | Plane Iii, Inc. | 1988-02-18 |
| TUMORIMETER (K874352) | Cancer Technologies, Inc. | 1987-11-23 |
| TEMPLATE (K873470) | Cox-Uphuff Intl. | 1987-09-08 |
| LN 100 BREAST MARKER (K872319) | Instrumentation Industries, Inc. | 1987-08-11 |
| KUNDIN WOUND GAUGE (K863409) | Jane I. Kundin | 1986-09-29 |
| PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN) (K862576) | Professional Services For Surgeons, Ltd. | 1986-07-15 |
| PS2 BRAND MAMMAPLASTY (K860912) | Professional Services For Surgeons, Ltd. | 1986-03-24 |
| RULER (K854892) | Euro-Med Intl. | 1985-12-24 |
| MOLE-MARKER (K840651) | Notation Systems, Inc. | 1984-03-12 |
| ZIMMER OSSIMETER (K832899) | Zimmer, Inc. | 1983-10-14 |
| SAGITTAL KNEE TESTER (K831041) | Orthopedic Systems, Inc. | 1983-06-24 |
| DRAWER TEST (K812713) | Medmetric Corp. | 1981-11-05 |
| BORES* DEPTH GAUGE (K812069) | Santa Barbara Medco, Inc. | 1981-08-31 |
| EXTENDED TUMOR CALIPER (K811278) | Mick Radio-Nuclear Instruments, Inc. | 1981-06-02 |
| RHYTIDOMETER (K801939) | Aztec Medical Products, Inc. | 1980-09-26 |
| PROXIMATE (TMD) TISSUE MEASURING DEVICE (K801374) | ETHICON, Inc. | 1980-06-26 |
| SURGICAL RULER (K790660) | Richard-Allan Medical Ind., Inc. | 1979-04-12 |
| TAPE MEASURE (K790089) | Pfizer, Inc. | 1979-03-06 |
Track FTY automatically
Every clearance here is in the API, with alerts when new ones post.