510(k) · Cleared
ClearedVenti.Plus Hyperinflation Bag System with Pressure Manometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A Plus Medical · NHK Resuscitator, Manual, Non Self-Inflating
Cleared on Nov 23, 2009 as substantially equivalent to K970785 (Sims, 1997) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Nov 23, 2009
- Review
- 83 days
- Class
- Class II
- Product code
- NHK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961318 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK961318 1ST Response Disposable ManometerIntertech Resources, Inc. · 1996
- This deviceK092687 Venti.Plus Hyperinflation Bag System with Pressure ManometerA Plus Medical · 2009
- Descendant · cites it directly · 0 of its ownK102377 Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable…A Plus Medical · 2010
Most influential descendants
Showing 1 of 1 · See all- K102377Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O…A Plus Medical · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961318 | 1ST Response Disposable Manometer | Intertech Resources, Inc. | 1996 | — |
| 0 (this device) | K092687 | Venti.Plus Hyperinflation Bag System with Pressure Manometer | A Plus Medical | 2009 | — |
| +1 | K102377 | Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer… | A Plus Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 NHK? 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? (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 |
|---|---|---|---|
| * | K970785 | Sims Hyperinflation Bag SystemSummary page 1…ode: CAP Regulation: CFR 868.2600 Device Class: II Device: Venti*Plus Hyperinflation Bag System with Pressure Manometer Predicate Devices: Number: K970785 Product Name: SIMS Hyperinflation Bag System Manufacturer: Smiths Medical (Intertech Resources) Product Codes: 008330D… | 1997 |
| * | K961318 | 1ST Response Disposable ManometerSummary page 1…008430, 008430DM, 00843M, 008430T,, 008430VM, 00843 IT, 008432, 008432DM, 008432T, 008435 & 008435DM Number: K961318 Product Name: 1' Response Disposable Manometer Manufacturer: Smiths Medical (Intertech Resources) Product Codes: 00820… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102377 | Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O… | 2010 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K102377 (A Plus Medical, 2010) has gone furthest, with 0 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. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092687 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092687: Venti.Plus Hyperinflation Bag System with Pressure Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092687
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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