510(k) · Cleared
ClearedivWatch Model 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivwatch, LLC · PMS Peripheral Intravenous (Piv) Infiltration Monitor
Cleared on Aug 24, 2022 as substantially equivalent to K162478 (Ivwatch, LLC, 2016) after a 30-day review. Its family tree reaches back 8 generations to 1990. 4 of the 13 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 24, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- PMS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904518 (1990). 12 ancestors in all. No later device cites it as a predicate yet. 4 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 7 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 6 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 5 generations backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- 4 generations backK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- 3 generations backK142374 ivWatch Model 400Ivwatch, LLC · 2015
- 2 generations backK153605 ivWatch Model 400Ivwatch, LLC · 2016
- 1 generation backK162478 ivWatchIvwatch, LLC · 2016
- This deviceK222212 ivWatch Model 400Ivwatch, LLC · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −7 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −6 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −5 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| −4 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| −3 | K142374 | ivWatch Model 400 | Ivwatch, LLC | 2015 | — |
| −2 | K153605 | ivWatch Model 400 | Ivwatch, LLC | 2016 | — |
| −1 | K162478 | ivWatch | Ivwatch, LLC | 2016 | — |
| 0 (this device) | K222212 | ivWatch Model 400 | Ivwatch, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PMS device
- #1 K233881 ivWatch® Model 400score 9.4 · 9 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K162478 | ivWatchSummary page 4…eral Intravenous (PIV) Infiltration Monitor Predicate Device Trade Name ivWatch® Model 400 Manufacturer ivWatch®, LLC 510(k) Number K162478 Device Class II Regulation Number 21 CFR 880.5725 Product Code PMS Common Name Periph… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 4 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · 5 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 12 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K162478.
How does its category compare?
All PMS devicesPMS Peripheral Intravenous (Piv) Infiltration Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PMS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PMS
Too few PMS 510(k)s in any year since 2007 to give a median.
Recalls per year · PMS
No recall names PMS since 2007.
Adverse event reports per year · PMS
1in 2022
MAUDE reports naming product code PMS, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations, but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222212 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222212: ivWatch Model 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222212
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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