# K953546: Manual Pulmonary Resusicitator

- Pathway: 510(k) (Traditional)
- Applicant: Medical Marketing Concepts
- Decided: Feb 29, 1996 after 216 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 16 (2 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 1, 2025 · Class I · Z-1814-2025: Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption o
- May 24, 2018 · Class II · Z-2148-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2156-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2154-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2158-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2147-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2149-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2150-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2145-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2153-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2155-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2152-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2146-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2151-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 24, 2018 · Class II · Z-2157-2018: There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
- May 16, 2014 · Class I · Z-1948-2014: The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.

Source page: https://510kreport.com/device/K953546
Methodology: https://510kreport.com/methodology