# K934475: Koko Filter II

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonary Data Services Inst., Inc.
- Decided: Oct 21, 1993 after 37 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 5 cite it directly.
0 of 8 devices 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.

## Most influential descendants
- K013123: Ems Pulmonary Function Testing Filter (2002), 3 descendants of its own
- K043148: All Flow Pulmonary Function Filter (2004), 2 descendants of its own
- K051712: Model 2800 PFT Filter (2005), 1 descendant of its own
- K142303: NeumoFilt Ergo/Neumo Filt BiteOn (2014), 0 descendants of its own
- K121382: Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)] (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K934475
Methodology: https://510kreport.com/methodology