510(k) · Cleared
ClearedEmt Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O-Two Systems Intl., Inc. · BTL Ventilator, Emergency, Powered (Resuscitator)
Cleared on Oct 29, 1998 as substantially equivalent to K932170 (O-Two Systems Intl., Inc., 1993) after an 8-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 29, 1998
- Review
- 8 days
- Class
- Class II
- Product code
- BTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932170 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK932170 Flynnr Genesis II a/C, a/O and IdlhO-Two Systems Intl., Inc. · 1993
- This deviceK983705 Emt ResuscitatorO-Two Systems Intl., Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932170 | Flynnr Genesis II a/C, a/O and Idlh | O-Two Systems Intl., Inc. | 1993 | — |
| 0 (this device) | K983705 | Emt Resuscitator | O-Two Systems Intl., Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K932170 | Flynnr Genesis II a/C, a/O and IdlhSummary page 1…or COMMON NAME: AUTOMATIC RESUSCITATOR REGULATORY CLASS: i 510K # : TO BE SUPPLIED LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED: GENESIS® Il A/C - 510K #. K932170 DESCRIPTION OF THE DEVICE: The EMT automatic/manually triggered resuscitators are designed to provide respiratory support to pa… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K932170.
How does its category compare?
All BTL devicesBTL Ventilator, Emergency, Powered (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Pulmonary resuscitation during respiratory and/or cardiac arrest.
Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
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/K983705 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983705: Emt Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983705
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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