# K030136: Drip Alert

- Pathway: 510(k) (Traditional)
- Applicant: Drip Alert, Inc.
- Decided: Apr 7, 2003 after 83 days
- Product code: FLN (Monitor, Electric For Gravity Flow Infusion Systems)
- Device class: 2
- Regulation: 21 CFR 880.2420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002211 (2000). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022248: Stryker L3 Hydrolert, Stryker Endoscopy (2002)
- K012383: Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii), Medsystem Patient C, Alaris Medical Systems, Inc. (2001)
- K950766: Sigma 8000 and Sigma 8002, Sigma Intl. General Medical Apparatus, Inc. (1995)

## Most influential descendants
- K150687: DripAssist (2015), 1 descendant of its own
- K172242: DripAssist Plus (2018), 0 descendants of its own
- K133870: Fluid Level Monitor (2014), 0 descendants of its own

## Indications for use
The Drip Alert device is intended to be used as a supplementary monitor with a standard IV administration set such that an alarm sounds when the drip rate in the drip chamber of the administration set falls outside a preselected range of acceptable drip rate deviation. The deviation in the drip rate may be due to air in the IV line, occlusion, excessive movement by the patient or displacement of the IV catheter.

Source page: https://510kreport.com/device/K030136
Methodology: https://510kreport.com/methodology