510(k) · Cleared
ClearedFilteredFlo Warming Blankets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iob Medical, Inc. · DWJ System, Thermal Regulating
Cleared on Oct 24, 2023 as substantially equivalent to K231596 (Iob Medical, Inc., 2023) after a 55-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Oct 24, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021473 (2002). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK021473 Bair Hugger Temperature Management SystemAugustine Medical, Inc. · 2002
- 3 generations backK162679 IOB Temperature Management SystemIob Medical, Inc. · 2017
- 2 generations backK190221 IOB Warming BlanketsIob Medical, Inc. · 2019
- 1 generation backK231596 IOB Temperature Management SystemIob Medical, Inc. · 2023
- This deviceK232638 FilteredFlo Warming BlanketsIob Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021473 | Bair Hugger Temperature Management System | Augustine Medical, Inc. | 2002 | — |
| −3 | K162679 | IOB Temperature Management System | Iob Medical, Inc. | 2017 | — |
| −2 | K190221 | IOB Warming Blankets | Iob Medical, Inc. | 2019 | — |
| −1 | K231596 | IOB Temperature Management System | Iob Medical, Inc. | 2023 | — |
| 0 (this device) | K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 DWJ? 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 DWJ device
- #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K231596 | IOB Temperature Management SystemSummary page 4…ets Common or Usual Name: Warming Blanket Classification Name: Thermal Regulating System (21 CFR 870.5900) Regulatory Class: II Product Code: DWJ III. PREDICATE DEVICE K231596 IOB Temperature Management System Model IOB-507 IV. DEVICE DESCRIPTION The FilteredFlo warming blankets are used with the IOB Te… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K231596.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 2025
MAUDE reports naming product code DWJ, 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 | 4 | 106 | 0 | 52 |
| 2008 | 3 | 73 | 0 | 40 |
| 2009 | 3 | 106 | 6 | 71 |
| 2010 | 8 | 134 | 2 | 104 |
| 2011 | 4 | 180 | 7 | 136 |
| 2012 | 5 | 69 | 1 | 106 |
| 2013 | 5 | 77 | 2 | 73 |
| 2014 | 4 | 131 | 0 | 116 |
| 2015 | 0 | — | 1 | 245 |
| 2016 | 2 | — | 0 | 1,400 |
| 2017 | 5 | 153 | 3 | 1,473 |
| 2018 | 3 | 95 | 5 | 1,517 |
| 2019 | 2 | — | 3 | 2,294 |
| 2020 | 5 | 30 | 2 | 2,546 |
| 2021 | 2 | — | 1 | 2,689 |
| 2022 | 2 | — | 5 | 3,226 |
| 2023 | 6 | 42 | 0 | 3,455 |
| 2024 | 2 | — | 3 | 3,329 |
| 2025 | 3 | 131 | 0 | 2,384 |
| 2026 | 5 | 99 | 3 | — |
What is it indicated for?
The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232638: FilteredFlo Warming Blankets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232638
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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