Curity Peakometer
FDA 510(k) K771655 · Kendall Research Center
510(k) numberK771655
Submission
- Device name
- Curity Peakometer
- Applicant
- Kendall Research Center
Mchenry, IL, US - Received
- August 29, 1977
- Decision date
- October 14, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893827 | Peak Flow Rate MeterFFG · Traditional | Laytech Medical Co. | 08/11/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | Medical Engineering Corp. | 02/08/1989SE |
| K850169 | Eris Uro-Diagnostic SystemFFG · Traditional | Eris Medical Technology | 04/22/1985SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | Epcom Medical Systems, Inc. | 02/25/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K843441 | Urinary Drainage Container 2012-WITHFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K844030 | Accumeter Electronic Urinemeter SystemFFG · Traditional | Travenol Laboratories, S.A. | 11/20/1984SE |
| K843224 | Uropump Model 1711FFG · Traditional | Life-Tech Intl., Inc. | 10/19/1984SE |
| K833043 | UrometerFFG · Traditional | Browne Medical, Inc. | 02/04/1984SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | Vital Metrics, Inc. | 03/01/1982SE |
More from Vital Metrics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802225 | Tender-Sorb Drain SpongesNAB · Traditional | 09/26/1980SE |
| K781357 | T.E.D. Sequential Compression SleevesJOW · Traditional | 09/20/1978SE |
| K780408 | Micronet Light Dressing SpongeNAB · Traditional | 03/22/1978SE |
| K780062 | Catheter/Hemostatic/GeriatricEZL · Traditional | 02/14/1978SE |
| K780120 | Anesthesia Tray, CaudalCAZ · Traditional | 02/06/1978SE |
| K772134 | Syringe, Irrigation, Pre-FilledKOA · Traditional | 11/28/1977SE |
| K772133 | Urine Specimen Collecting DeviceFCN · Traditional | 11/28/1977SE |
| K771079 | Curity Irrigation TrayGBX · Traditional | 09/15/1977SE |
| K771563 | Conform Elastic NettingFQM · Traditional | 09/12/1977SE |
| K771452 | Conform Stretch Bandage (5SIZES)ITG · Traditional | 09/12/1977SE |
Questions and answers
When was Curity Peakometer cleared by the FDA?
Curity Peakometer (K771655) received a 510(k) decision of Substantially Equivalent on October 14, 1977, 46 days after the submission was received.
What is the product code of K771655?
The FDA product code is FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.1800.