# K970991: Datex Engstom Manual Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Promedic, Inc.
- Decided: Jun 16, 1997 after 89 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895589 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895589: Manual Resuscitator, Hudson Oxygen Therapy Sales Co. (1990) Summary page 1.
- K902062: Peep Valve, Hudson Oxygen Therapy Sales Co. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K910441: Floscope Microdop, Advance Medical Device, Inc. (1991). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K970991
Methodology: https://510kreport.com/methodology