510(k) · Cleared
ClearedHyperinflation Bag System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nutec, Inc. · NHK Resuscitator, Manual, Non Self-Inflating
Cleared on Feb 17, 1994 after a 29-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Feb 17, 1994
- Review
- 29 days
- Class
- Class II
- Product code
- NHK
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK940255 Hyperinflation Bag SystemNutec, Inc. · 1994
- Descendant · cites it directly · 4 of its ownK971923 Drager-Vapor 2000Draeger Medical, Inc. · 1997 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK042276 D-VaporDraeger Medical, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 0 of its ownK240375 V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK150167 V60 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK060331 Sigma Alpha VaporizerPenlon Limited · 2006
Class I recalls in this family
- K971923 Drager-Vapor 2000cites it directly · 1997
Most influential descendants
Showing 5 of 5 · See all- K971923Drager-Vapor 2000Draeger Medical, Inc. · 1997 · cites it directly4descendants
- K042276D-VaporDraeger Medical, Inc. · 2004 · 2 generations on2descendants
- K240375V80 Anesthetic Vaporizer (V80)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2024 · 3 generations on0descendants
- K150167V60 Anesthetic VaporizerShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on0descendants
- K060331Sigma Alpha VaporizerPenlon Limited · 2006 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940255 | Hyperinflation Bag System | Nutec, Inc. | 1994 | — |
| +1 | K971923 | Drager-Vapor 2000 | Draeger Medical, Inc. | 1997 | Class I |
| +2 | K042276 | D-Vapor | Draeger Medical, Inc. | 2004 | 1 |
| +3 | K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024 | — |
| +2 | K150167 | V60 Anesthetic Vaporizer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K060331 | Sigma Alpha Vaporizer | Penlon Limited | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971923 | Drager-Vapor 2000 Class I | 1997 | 4 |
Has anything in its family been recalled? (1 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.
- K971923Drager-Vapor 2000Draeger Medical, Inc. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K971923 (Draeger Medical, Inc., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NHK devicesNHK Resuscitator, Manual, Non Self-Inflating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHK
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NHK
Too few NHK 510(k)s in any year since 2007 to give a median.
Recalls per year · NHK
No recall names NHK since 2007.
Adverse event reports per year · NHK
2in 2025
MAUDE reports naming product code NHK, 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 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K940255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940255: Hyperinflation Bag System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940255
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026