# K801694: Flotation Pad for Operating Table

- Pathway: 510(k) (Traditional)
- Applicant: Action Products, Inc.
- Decided: Aug 27, 1980 after 35 days
- Product code: FMP (Protector, Skin Pressure)
- Device class: 1
- Regulation: 21 CFR 880.6450
- 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; 1 cites it directly.
5 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
- K021077: Mega 2000 Soft Patient Return Electrode Pad (2002), 6 descendants of its own
- K031285: Mega 2000 Soft Dual Cord Patient Return Electrode Pad (2003), 5 descendants of its own
- K080741: Mega Soft Reusable Patient Return Electrode (2008), 4 descendants of its own
- K133726: Mega Soft Universal Patient Return Electrode (2014), 3 descendants of its own
- K233644: Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K801694
Methodology: https://510kreport.com/methodology