510(k) · Cleared
ClearedSave-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Automedx, Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Sep 6, 2007 as substantially equivalent to K931473 (Impact Instrumentation, Inc., 1994) after a 127-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Sep 6, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931473 (1994). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K131877Save II, Save II BasicAutomedx, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931473 | Impact Model 753 | Impact Instrumentation, Inc. | 1994 | — |
| 0 (this device) | K071221 | Save-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12 | Automedx, Inc. | 2007 | — |
| +1 | K131877 | Save II, Save II Basic | Automedx, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 BTL? 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 BTL device
- #1 K242769 VentStar Resus heated (N) (MP17030); VentStar…score 11.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K931473 | Impact Model 753Summary page 1…(301) 916-7155 Classification Name Ventilator, Emergency, Powered, (Resuscitator) Regulation Number . 868.5925 FDA CDbk. Predicate Device JAN 1 8 Impact Uni-Vent 754 (K931473) Intended Use / Indications for Use Recewed The SAVe is intended for use on adults that need ventilatory support. Specifically,… | 1994 |
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 |
|---|---|---|---|
| K131877 | Save II, Save II Basic | 2014 | 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?
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · BTL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTL
203in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTL
2in 2024
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · BTL
165in 2025
MAUDE reports naming product code BTL, 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 | 5 | 122 | 1 | 5 |
| 2008 | 4 | 198 | 0 | 37 |
| 2009 | 5 | 173 | 0 | 69 |
| 2010 | 3 | 140 | 0 | 96 |
| 2011 | 2 | — | 1 | 75 |
| 2012 | 0 | — | 2 (2) | 115 |
| 2013 | 1 | — | 3 (1) | 103 |
| 2014 | 7 | 203 | 0 | 70 |
| 2015 | 1 | — | 3 (2) | 79 |
| 2016 | 0 | — | 0 | 80 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 1 | — | 0 | 197 |
| 2019 | 1 | — | 3 (3) | 341 |
| 2020 | 1 | — | 0 | 454 |
| 2021 | 1 | — | 1 | 506 |
| 2022 | 0 | — | 0 | 755 |
| 2023 | 1 | — | 0 | 731 |
| 2024 | 0 | — | 2 (2) | 667 |
| 2025 | 1 | — | 0 | 165 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SAVe is intended for use on adults that need ventilatory support. Specifically, the SAVe is intended to provide short term ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. The SAVe device is appropriate for individuals that weigh at least 45 kilograms. It is intended to be used in field hospitals, transport and pre-hospital environments.
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/K071221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071221: Save-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071221
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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