510(k) · Cleared
ClearedSnowden-Pencer Computerized High Flow Insufflator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deknatel, Inc. · HIF Insufflator, Laparoscopic
Cleared on Jan 10, 1997 as substantially equivalent to K920986 (Snowden-Pencer, 1992) and 1 other predicate after a 184-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Jan 10, 1997
- Review
- 184 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920986 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920986 Snowden-Pencer High Flow Insufflator, SP/88-9700Snowden-Pencer · 1992
- This deviceK962683 Snowden-Pencer Computerized High Flow InsufflatorDeknatel, Inc. · 1997
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) | K962683 | Snowden-Pencer Computerized High Flow Insufflator | Deknatel, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (2)
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 |
|---|---|---|---|
| * | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700Summary page 2…ntended use to other high flow insufflators currently in commercial distribution in the United States. The predecessor Snowden-Pencer Computerized High Flow Insufflator (K920986) had many of the identical features to the current model device with the exception of the continuous monitoring of patient pressu… | 1992 |
| * | K952508 | Flow-Therme, Wisap #7642Summary page 2…been added to the device in order to improve device performance and user convenience. Other electronic high flow insufflators, such as the WISAP Flow Therme Insufflator (K952508) also include a CO, heater. 6. DEVICE TESTING Performance testing conducted on the Snowden-Pencer Computerized High Flow Insuff… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 ancestors has a recall.
- 1 other device also cites its predicate K920986.
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 Snowden-Pencer Computerized High Flow Insufflator is intended to provide intra-abdominal distention 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/K962683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962683: Snowden-Pencer Computerized High Flow Insufflator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962683
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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