510(k) · Cleared
ClearedSV70 Ventilator (SV70)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Apr 6, 2026 as substantially equivalent to K082660 (Respironics California, Inc., 2009) and 1 other predicate after a 269-day review. Its family tree reaches back 7 generations to 1983. 3 of the 21 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 6, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K833786 (1983). 20 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 3 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 6 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 5 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 4 generations backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- 3 generations backK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)
- 2 generations backK102985 V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · Recalled (Class I)
- 1 generation backK213521 Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc. · 2022
- This deviceK252182 SV70 Ventilator (SV70)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −6 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −5 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −4 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| −3 | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | Class I |
| −2 | K102985 | V60 Ventilator with PPV and Auto-Trak+ Software Options | Respironics, Inc. | 2011 | Class I |
| −1 | K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022 | — |
| 0 (this device) | K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 1 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K082660 | V60 Ventilator, Model V8000Summary page 5…oduct Code: MNT Panel: Anesthesiology 3. PREDICATE DEVICES Primary Predicate Device: K082660, V60 Ventilator, Respironics Inc Secondary Predicate Device: K213521, NKV-330 Ventilator, Nihon Kohde… | 2009 |
| * | K213521 | Nihon Kohden NKV-330 Ventilator SystemSummary page 5…PREDICATE DEVICES Primary Predicate Device: K082660, V60 Ventilator, Respironics Inc Secondary Predicate Device: K213521, NKV-330 Ventilator, Nihon Kohden OrangeMed, Inc - Supports Ventilation Mode: S mode, O2 Therapy mode.… | 2022 |
| † | K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | 2023 |
| † | K193228 | Hamilton-G5 | 2020 |
| † | K213799 | N Series Patient Monitors | 2022 |
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.
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 2 generations back · ◆ on the line of descent in FIG. 18 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 43 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 8 of the 20 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K082660.
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. 2026, 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 SV70 Ventilator is intended for use in a professional healthcare facility or during transport in a professional healthcare facility.
The SV70 Ventilator is intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 20 kg, who are spontaneously breathing individuals with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea.
The SV70 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252182: SV70 Ventilator (SV70).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252182
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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