FLUID LEVEL MONITOR
FDA 510(k) clearance K133870 · decided 2014-04-24
Clearance details
- K-number
- K133870
- Device name
- FLUID LEVEL MONITOR
- Applicant
- Coleman Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2013-12-20
- Decision date
- 2014-04-24
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- FLN
- Device class
- 2
- Regulation number
- 880.2420
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- King Of Prussia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DripAssist Plus (K172242) | Shift Labs, Inc. | 2018-05-25 |
| DripAssist (K150687) | Shift Labs | 2015-10-13 |
| LOW FLUID ALARM (K080704) | Em-Tec GmbH | 2008-04-17 |
| ISSYS DRUG FLOW MONITOR (K050783) | Integrated Sensing Systems, Inc. | 2006-02-22 |
| LEVELERT II FLUID LEVEL SENSOR (K060123) | Smith & Nephew, Inc. | 2006-02-14 |
| DRIP ALERT (K030136) | Drip Alert, Inc. | 2003-04-07 |
| STRYKER L3 HYDROLERT (K022248) | Stryker Endoscopy | 2002-08-06 |
| MT ALERT INFUSION MONITOR (K013121) | Sierra Biosearch, Inc. | 2001-10-15 |
| FLUID CENTURION (4-100-00) (K973025) | Northgate Technologies, Inc. | 1997-11-20 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (K972084) | Alexander Mfg. Co. | 1997-07-03 |
| AC-901 I.V. INFUSION DROP COUNTER (K923561) | Lamtic, Inc. | 1993-05-26 |
| BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) (K910323) | Uab Research Foundation | 1991-10-03 |
Recalls involving this device
No recalls on record reference this clearance.