510(k) · Cleared
ClearedInter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled Hmef
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intersurgical Incorporated · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Feb 12, 2015 as substantially equivalent to K941381 (Mallinckrodt Medical, 1994) after a 290-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 12, 2015
- Review
- 290 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941381 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- This deviceK141087 Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled HmefIntersurgical Incorporated · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| 0 (this device) | K141087 | Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled Hmef | Intersurgical Incorporated | 2015 | — |
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 CAH? 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 CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 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 |
|---|---|---|---|
| * | K941381 | Hygrobac,S Hygroboy and HygrobabySummary page 4…erm Mini Pediatric angled HMEF sterile (Product #1332030S) are substantially equivalent to the Covidien 355U5430 DAR Infant - Pediatric Electrostatic Filter HME (Small — K941381- Hygroboy). The 355U5430 DAR HMEF is a heat and moisture exchanger that allows for heated humidified air to be supplied to the p… | 1994 |
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K941381.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, 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 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24…
Read the full statement (133 words)
The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to < 30 days. The recommended pediatric weight range is 11 kg to 35 kg. The recommended tidal volume is 75 to 250 ml.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141087 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141087: Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled Hmef.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141087
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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