# K873286: Disposable, Manual Pulmonary Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Hospitak, Inc.
- Decided: Oct 26, 1987 after 70 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 6, 2009 · Not classified · Z-0046-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0045-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0048-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0053-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0040-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0041-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0042-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0043-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0051-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0052-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0054-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0039-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0044-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0047-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0049-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0050-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0055-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0056-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0057-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0058-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0070-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0071-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose
- Oct 6, 2009 · Not classified · Z-0072-2010: In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose

Source page: https://510kreport.com/device/K873286
Methodology: https://510kreport.com/methodology