# K832761: Air Fluid Exchange Pump

- Pathway: 510(k) (Traditional)
- Applicant: Intek Int'L, Inc.
- Decided: Oct 19, 1983 after 61 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K962131: Storz D4600 Air Exchange Line Pack (1996), 2 descendants of its own
- K082132: Bausch & Lomb D4600A Air Exchange Line Pack (2008), 0 descendants of its own
- K990292: I/a (Irrigation/Aspiration) Pack, Posterior Vitrecomy Pack, Anterior Virectomy Pack, Phacoemulsification Pack, Admiinisn (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K832761
Methodology: https://510kreport.com/methodology