510(k) · Cleared
ClearedStryker L3 Hydrolert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · FLN Monitor, Electric For Gravity Flow Infusion Systems
Cleared on Aug 6, 2002 after a 25-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Aug 6, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- FLN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK022248 Stryker L3 HydrolertStryker Endoscopy · 2002
- Descendant · cites it directly · 3 of its ownK030136 Drip AlertDrip Alert, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK150687 DripAssistShift Labs · 2015
- Descendant · 3 generations on · 0 of its ownK172242 DripAssist PlusShift Labs, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK133870 Fluid Level MonitorColeman Laboratories · 2014
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022248 | Stryker L3 Hydrolert | Stryker Endoscopy | 2002 | — |
| +1 | K030136 | Drip Alert | Drip Alert, Inc. | 2003 | — |
| +2 | K150687 | DripAssist | Shift Labs | 2015 | — |
| +3 | K172242 | DripAssist Plus | Shift Labs, Inc. | 2018 | — |
| +2 | K133870 | Fluid Level Monitor | Coleman Laboratories | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Smith & Nephew Dyonics LeveLert System Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030136 | Drip Alert | 2003 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030136 (Drip Alert, Inc., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FLN devicesFLN Monitor, Electric For Gravity Flow Infusion Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLN
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · FLN
Too few FLN 510(k)s in any year since 2007 to give a median.
Recalls per year · FLN
No recall names FLN since 2007.
Adverse event reports per year · FLN
2in 2025
MAUDE reports naming product code FLN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022248: Stryker L3 Hydrolert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022248
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026