510(k) · Decided
DecidedDatex Engstom Manual Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedic, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Jun 16, 1997 as substantially equivalent to K895589 (Hudson Oxygen Therapy Sales Co., 1990) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 16, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K895589 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895589 Manual ResuscitatorHudson Oxygen Therapy Sales Co. · 1990
- This deviceK970991 Datex Engstom Manual ResuscitatorPromedic, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895589 | Manual Resuscitator | Hudson Oxygen Therapy Sales Co. | 1990 | — |
| 0 (this device) | K970991 | Datex Engstom Manual Resuscitator | Promedic, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 BTM? 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 BTM device
- #1 K243861 butterflyBVMscore 9.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K910441 | FDA’s K910441 is Floscope Microdop Our OCR of the scanned summary read K910441, FDA’s number for Floscope Microdop (Advance Medical Device, Inc.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 1…20109 S-16102 Bromma SWEDEN Tel - 011-46-8-629-3100 Official Contact: Proprietary or Trade Name: Common/Usual Name: Classification Name: Device: Predicate Devices: K910441 Non-Confidential Summary of Safety and Effectiveness JUN 16 page 1 of 3 March 12, 1997 Fax - 011-46-8-298418 Arne Salo, Presi… | 1991 |
| * | K895589 | Manual ResuscitatorSummary page 1…l resuscitator Manual resuscitator Ventilator, Emergency, Manual (Resuscitator) Datex Engstrom Reusable Manual Resuscitator Hudson RCI - Durable Manual resuscitator - K895589 Hudson RCI - PEEP valves - K902062 |Device Description: | The Datex Engstrom manual resuscitator is designed for use as an adj… | 1990 |
| * | K902062 | Peep ValveSummary page 1…Ventilator, Emergency, Manual (Resuscitator) Datex Engstrom Reusable Manual Resuscitator Hudson RCI - Durable Manual resuscitator - K895589 Hudson RCI - PEEP valves - K902062 |Device Description: | The Datex Engstrom manual resuscitator is designed for use as an adjunct to artificial respiration and… | 1990 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, 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 | 2 | — | 0 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
To ventilate the apnoeic patient and to augment ventilation
and / or oxygen delivery to the spontaneously breathing
patient. For use as an adjunct to artificial respiration and
cardiopulmonary resuscitation.
Hospital - Emergency Medical Services, Operating Room,
during patient transport, Intensive Care Units, where patient
assisted ventilation may be administered or required.
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/K970991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970991: Datex Engstom Manual Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970991
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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