# K970866: Filter Heater/Hydrator Insufflation Gas Conditioner

- Pathway: 510(k) (Traditional)
- Applicant: Georgia Biomedical, Inc.
- Decided: Jan 23, 1998 after 319 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920986 (1992). 4 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941438: OP-Pneu Electronic CO2, Wisap/U.S.A. (1995) Summary page 2.
- K952508: Flow-Therme, Wisap #7642, Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (1995) Summary page 2.
- K920205: Ott Insufflation Filter Tubing, Georgia Biomedical Research Group, Inc. (1993) Summary page 2.
- K920986: Snowden-Pencer High Flow Insufflator, SP/88-9700, Snowden-Pencer (1992) Summary page 2.

## Most influential descendants
- K063546: Insuflow Device, Model 6198 (2007), 13 descendants of its own
- K090456: Insuflow (2009), 9 descendants of its own
- K120640: Insuflow Synergy Port (2012), 5 descendants of its own
- K132204: Insuflow Synergy XL Port (2013), 3 descendants of its own
- K140263: Insuflow Synergy Port, Insuflow Synergy XL Port (2014), 2 descendants of its own

## Indications for use
The Georgia BioMedical Filter Heater/ Hydrator Insufflation Gas Conditioner is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.

Source page: https://510kreport.com/device/K970866
Methodology: https://510kreport.com/methodology