# K022248: Stryker L3 Hydrolert

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Aug 6, 2002 after 25 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew Dyonics LeveLert System: named in the summary without a submission number

## Most influential descendants
- K030136: Drip Alert (2003), 3 descendants of its own
- 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 Stryker L3 Hydrolert is intended to monitor irrigant levels primarily during arthroscopic procedures and to alert operating room personnel of a low irrigant fluid level condition. It will offer both increased efficiency in arthroscopic procedures and universal compatibility with both arthroscopic pump and gravity fluid management systems. It is intended for use with saline solution or any other standard irrigant. It is not intended for use as an intravenous infusion monitor. The alarm is designed to be reusable.

Source page: https://510kreport.com/device/K022248
Methodology: https://510kreport.com/methodology