510(k) · Cleared
ClearedFilter Heater/Hydrator Insufflation Gas Conditioner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Georgia Biomedical, Inc. · HIF Insufflator, Laparoscopic
Cleared on Jan 23, 1998 as substantially equivalent to K941438 (Wisap/U.S.A., 1995) and 3 other predicates after a 319-day review. Its family tree reaches back 1 generation to 1992. 14 later devices descend from it.
- Decided
- Jan 23, 1998
- Review
- 319 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K920986 (1992). 4 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920986 Snowden-Pencer High Flow Insufflator, SP/88-9700Snowden-Pencer · 1992
- This deviceK970866 Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998
- Descendant · cites it directly · 13 of its ownK063546 Insuflow Device, Model 6198Lexion Medical, LLC · 2007
- Descendant · 2 generations on · 9 of its ownK090456 InsuflowLexion Medical, LLC · 2009
- Descendant · 3 generations on · 5 of its ownK120640 Insuflow Synergy PortLexion Medical, LLC · 2012
- Descendant · 4 generations on · 3 of its ownK132204 Insuflow Synergy XL PortLexion Medical, LLC · 2013
- Descendant · 4 generations on · 2 of its ownK140263 Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K063546Insuflow Device, Model 6198Lexion Medical, LLC · 2007 · cites it directly13descendants
- K090456InsuflowLexion Medical, LLC · 2009 · 2 generations on9descendants
- K120640Insuflow Synergy PortLexion Medical, LLC · 2012 · 3 generations on5descendants
- K132204Insuflow Synergy XL PortLexion Medical, LLC · 2013 · 4 generations on3descendants
- K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC · 2014 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700 | Snowden-Pencer | 1992 | — |
| 0 (this device) | K970866 | Filter Heater/Hydrator Insufflation Gas Conditioner | Georgia Biomedical, Inc. | 1998 | — |
| +1 | K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC | 2007 | — |
| +2 | K090456 | Insuflow | Lexion Medical, LLC | 2009 | — |
| +3 | K120640 | Insuflow Synergy Port | Lexion Medical, LLC | 2012 | — |
| +4 | K132204 | Insuflow Synergy XL Port | Lexion Medical, LLC | 2013 | — |
| +4 | K140263 | Insuflow Synergy Port, Insuflow Synergy XL Port | Lexion Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HIF device
- #1 K250388 Endoflator +score 15.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941438 | OP-Pneu Electronic CO2Summary page 2…l. Georgia BioMedical, Inc. Additional Information for Filter Heater/Hydrator 7/1/97 Page C-1 |45t prn ) 3. PREDICATE DEVICES WISAP Op-Pneu subject of K941438, the WISAP Flow-Therme subject of K952508, the CO,Guard™ Insufflator Filter Tubing, Georgia BioMedical, Inc. subject of K920205 a… | 1995 |
| * | K952508 | Flow-Therme, Wisap #7642Summary page 2…formation for Filter Heater/Hydrator 7/1/97 Page C-1 |45t prn ) 3. PREDICATE DEVICES WISAP Op-Pneu subject of K941438, the WISAP Flow-Therme subject of K952508, the CO,Guard™ Insufflator Filter Tubing, Georgia BioMedical, Inc. subject of K920205 and the Snowden-Pencer Insufflator subject… | 1995 |
| * | K920205 | Ott Insufflation Filter TubingSummary page 2…EDICATE DEVICES WISAP Op-Pneu subject of K941438, the WISAP Flow-Therme subject of K952508, the CO,Guard™ Insufflator Filter Tubing, Georgia BioMedical, Inc. subject of K920205 and the Snowden-Pencer Insufflator subject of K920986. 4. INTENDED USE The Georgia BioMedical Filter Heater/Hydrator Insufflati… | 1993 |
| * | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700Summary page 2…WISAP Flow-Therme subject of K952508, the CO,Guard™ Insufflator Filter Tubing, Georgia BioMedical, Inc. subject of K920205 and the Snowden-Pencer Insufflator subject of K920986. 4. INTENDED USE The Georgia BioMedical Filter Heater/Hydrator Insufflation Gas Conditioner is an accessory to an insufflator i… | 1992 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063546 | Insuflow Device, Model 6198 | 2007 | 13 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 4 ancestors has a recall.
- Of its descendants, K063546 (Lexion Medical, LLC, 2007) has gone furthest, with 13 descendants of its own.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIF
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIF
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HIF
1,507in 2025
MAUDE reports naming product code HIF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 140 | 0 | 8 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 4 | 191 | 0 | 21 |
| 2010 | 2 | — | 0 | 41 |
| 2011 | 5 | 128 | 0 | 44 |
| 2012 | 5 | 138 | 0 | 38 |
| 2013 | 2 | — | 0 | 40 |
| 2014 | 2 | — | 0 | 43 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 3 | 88 | 1 | 72 |
| 2017 | 5 | 242 | 0 | 68 |
| 2018 | 3 | 207 | 1 | 97 |
| 2019 | 2 | — | 0 | 128 |
| 2020 | 4 | 64 | 0 | 360 |
| 2021 | 1 | — | 0 | 654 |
| 2022 | 1 | — | 0 | 667 |
| 2023 | 7 | 134 | 1 (1) | 890 |
| 2024 | 4 | 170 | 0 | 1,483 |
| 2025 | 3 | 210 | 0 | 1,507 |
| 2026 | 3 | 265 | 12 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970866: Filter Heater/Hydrator Insufflation Gas Conditioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970866
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026