FLN — Monitor, Electric For Gravity Flow Infusion Systems Class II
FDA product code FLN covers "Monitor, Electric For Gravity Flow Infusion Systems", a Class II medical device regulated under 21 CFR 880.2420. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FLN
- Device Class
- Class II
- Regulation Number
- 880.2420
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172242 | shift labs | DripAssist Plus | May 25, 2018 |
| K150687 | shift labs | DripAssist | October 13, 2015 |
| K133870 | coleman laboratories | FLUID LEVEL MONITOR | April 24, 2014 |
| K080704 | em-tec | LOW FLUID ALARM | April 17, 2008 |
| K050783 | integrated sensing systems | ISSYS DRUG FLOW MONITOR | February 22, 2006 |
| K060123 | smith and nephew | LEVELERT II FLUID LEVEL SENSOR | February 14, 2006 |
| K030136 | drip alert | DRIP ALERT | April 7, 2003 |
| K022248 | stryker endoscopy | STRYKER L3 HYDROLERT | August 6, 2002 |
| K013121 | sierra biosearch | MT ALERT INFUSION MONITOR | October 15, 2001 |
| K973025 | northgate technologies | FLUID CENTURION (4-100-00) | November 20, 1997 |
| K972084 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | July 3, 1997 |
| K923561 | lamtic | AC-901 I.V. INFUSION DROP COUNTER | May 26, 1993 |
| K910323 | uab research foundation | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) | October 3, 1991 |
| K902808 | trans-pacific healthcare-usa | DRIPTROL | October 1, 1990 |
| K903193 | smith and nephew dyonics | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | August 30, 1990 |
| K893693 | li-lien | H.U. I.V. DROP COUNTER | October 27, 1989 |
| K853843 | medtech intl | IV MATE | January 9, 1986 |
| K853549 | american mcgaw | MCGAW/DROP WATCH FLOW MONITOR | November 12, 1985 |
| K852433 | medix medical electronics (u.s.a.) | INFUSAFE 205 CATOLOG NO. 205.000 | June 27, 1985 |
| K850710 | travenol laboratories | TRAVENOL FLO-GARD 500 IV MONITOR | April 4, 1985 |