510(k) · Cleared
ClearedSims Hyperinflation Bag System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims · NHK Resuscitator, Manual, Non Self-Inflating
Cleared on Jun 13, 1997 after a 101-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 13, 1997
- Review
- 101 days
- Class
- Class II
- Product code
- NHK
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK970785 Sims Hyperinflation Bag SystemSims · 1997
- Descendant · cites it directly · 1 of its ownK092687 Venti.Plus Hyperinflation Bag System with Pressure ManometerA Plus Medical · 2009
- Descendant · 2 generations on · 0 of its ownK102377 Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable…A Plus Medical · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970785 | Sims Hyperinflation Bag System | Sims | 1997 | — |
| +1 | K092687 | Venti.Plus Hyperinflation Bag System with Pressure Manometer | A Plus Medical | 2009 | — |
| +2 | K102377 | Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer… | A Plus Medical | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092687 | Venti.Plus Hyperinflation Bag System with Pressure Manometer | 2009 | 1 |
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?
- Of its descendants, K092687 (A Plus Medical, 2009) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffeging from respiratory insufficiency. Typical treatment consists of hyperinflating the patient’s lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak…
Read the full statement (166 words)
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffeging from respiratory insufficiency. Typical treatment consists of hyperinflating the patient’s lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.
The SIMS Hyperinflation Bag System is a pulmonary-assist device intended to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag to prevent atelectasis. It is designed for patients suffeging from respiratory insufficiency. Typical treatment consists of hyperinflating the patient’s lung over several respiration cycles, each terminating in a preset PEEP (positive end expiratory pressure). Peak pressure is controlled by the user and monitored by means of a user-supplied manometer or optional disposable manometer.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970785: Sims 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/K970785
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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