510(k) · Cleared
ClearedHFT750U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mekics Co., Ltd. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on May 15, 2025 as substantially equivalent to K213521 (Nihon Kohden Orangemed, Inc., 2022) and 1 other predicate after a 232-day review. Its family tree reaches back 11 generations to 1992. 3 of the 56 devices in its family, counting itself, have a Class I recall.
- Decided
- May 15, 2025
- Review
- 232 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K913368 (1992). 55 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 3 of the 56 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 7 generations between
- 3 generations backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- 2 generations backK221338 F&P Airvo 3Fisher & Paykel Healthcare · 2023 · Recalled
- 1 generation backK233643 F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. · 2024
- This deviceK242931 HFT750UMekics Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 10 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 9 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 8 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 7 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 6 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 5 generations backK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- 4 generations backK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- 3 generations backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- 2 generations backK221338 F&P Airvo 3Fisher & Paykel Healthcare · 2023 · Recalled
- 1 generation backK233643 F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. · 2024
- This deviceK242931 HFT750UMekics Co., Ltd. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −10 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −9 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −8 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −7 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −6 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −5 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| −4 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| −3 | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | 2 |
| −2 | K221338 | F&P Airvo 3 | Fisher & Paykel Healthcare | 2023 | 1 |
| −1 | K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024 | — |
| 0 (this device) | K242931 | HFT750U | Mekics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 1 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2011 | 1 | 1 |
| 2018 | 1 | 0 |
| 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.
3 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 MNT device
- #1 K233643 F&P Airvo 3 NIV (PT311US)score 13.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K213521 | Nihon Kohden NKV-330 Ventilator SystemSummary page 5…ilator CFR: 868.5895 Product Classification: MNT Primary Predicate Device: Nihon Kohden NKV-330 - K213521 Classification Name: Continuous ventilator CFR: 868.5895 Product Classi… | 2022 |
| * | K233643 | F&P Airvo 3 NIV (PT311US)Summary page 5…868.5895 Product Classification: MNT Secondary Predicate Device: Fisher and Paykel – Airvo 3 NIV – K233643 Classification Name: Continuous ventilator CFR: 868.5895 Product Classi… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 18 Class I recalls
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 13 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 13 of the 55 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K213521.
How does its category compare?
All MNT devicesMNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MNT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNT
Too few MNT 510(k)s in any year since 2007 to give a median.
Recalls per year · MNT
5in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 2025
MAUDE reports naming product code MNT, 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 | — | 1 | 59 |
| 2008 | 1 | — | 0 | 76 |
| 2009 | 2 | — | 1 | 29 |
| 2010 | 0 | — | 1 | 63 |
| 2011 | 2 | — | 0 | 170 |
| 2012 | 2 | — | 0 | 257 |
| 2013 | 1 | — | 0 | 322 |
| 2014 | 0 | — | 0 | 887 |
| 2015 | 0 | — | 0 | 1,657 |
| 2016 | 0 | — | 0 | 2,515 |
| 2017 | 1 | — | 0 | 2,878 |
| 2018 | 0 | — | 0 | 2,203 |
| 2019 | 0 | — | 1 (1) | 9,350 |
| 2020 | 1 | — | 33 | 4,170 |
| 2021 | 0 | — | 0 | 3,790 |
| 2022 | 1 | — | 5 (5) | 3,277 |
| 2023 | 1 | — | 0 | 4,565 |
| 2024 | 2 | — | 0 | 4,808 |
| 2025 | 1 | — | 0 | 3,545 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. The device provides heated and humidified gas to the patient. The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways…
Read the full statement (112 words)
The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency.
The device provides heated and humidified gas to the patient.
The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included.
The High Flow mode has a flow range from 1 to 60 lpm.
The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician.
It is not intended for life support.
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/K242931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242931: HFT750U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242931
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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