510(k) · Cleared
ClearedDrip Alert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drip Alert, Inc. · FLN Monitor, Electric For Gravity Flow Infusion Systems
Cleared on Apr 7, 2003 as substantially equivalent to K022248 (Stryker Endoscopy, 2002) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 2000. 1 of the 9 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Apr 7, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- FLN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002211 (2000). 5 ancestors in all, the oldest K950766 (1995). 3 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK002211 Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric…Baxter Healthcare Corp · 2000 · Recalled
- 1 generation backK012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE)…Alaris Medical Systems, Inc. · 2001 · Recalled (Class I)
- This deviceK030136 Drip AlertDrip Alert, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK150687 DripAssistShift Labs · 2015
- Descendant · 2 generations on · 0 of its ownK172242 DripAssist PlusShift Labs, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK133870 Fluid Level MonitorColeman Laboratories · 2014
Class I recalls in this family
- K012383 Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition…direct predicate · 2001
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002211 | Colleague CX Volumetric Infusion Pump 2M8161 and Volumeteric Infusion Pump… | Baxter Healthcare Corp | 2000 | 4 |
| −1 | K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem… | Alaris Medical Systems, Inc. | 2001 | Class I |
| 0 (this device) | K030136 | Drip Alert | Drip Alert, Inc. | 2003 | — |
| +1 | K150687 | DripAssist | Shift Labs | 2015 | — |
| +2 | K172242 | DripAssist Plus | Shift Labs, Inc. | 2018 | — |
| +1 | K133870 | Fluid Level Monitor | Coleman Laboratories | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (3)
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.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K012383Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (SE), Medsystem Iii Infusion (Msiii)…Alaris Medical Systems, Inc. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150687 (Shift Labs, 2015) has gone furthest, with 1 descendant 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030136 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030136: Drip Alert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030136
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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