510(k) · Cleared
ClearedRedfield Infrared Coagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hogan & Hartson · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Mar 24, 1995 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 113 later devices descend from it.
- Decided
- Mar 24, 1995
- Review
- 28 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
113 later devices descend from it, 2 citing it directly.
- This deviceK950836 Redfield Infrared CoagulatorHogan & Hartson · 1995
- Descendant · cites it directly · 109 of its ownK974168 Coopersurgical Infrared CoagulatorHogan & Hartson · 1998
- Descendant · 2 generations on · 107 of its ownK060069 Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc. · 2006
- Descendant · 3 generations on · 64 of its ownK070298 Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007
- Descendant · 4 generations on · 57 of its ownK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- Descendant · 3 generations on · 56 of its ownK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K974168Coopersurgical Infrared CoagulatorHogan & Hartson · 1998 · cites it directly109descendants
- K060069Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc. · 2006 · 2 generations on107descendants
- K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007 · 3 generations on64descendants
- K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011 · 4 generations on57descendants
- K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011 · 3 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950836 | Redfield Infrared Coagulator | Hogan & Hartson | 1995 | — |
| +1 | K974168 | Coopersurgical Infrared Coagulator | Hogan & Hartson | 1998 | — |
| +2 | K060069 | Palomar Luxir Fractional Handpiece | Palomar Medical Technologies, Inc. | 2006 | — |
| +3 | K070298 | Modification to Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2007 | — |
| +4 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| +3 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 12 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 16 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (113)
See all 1132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K974168 (Hogan & Hartson, 1998) has gone furthest, with 109 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
https://510kreport.com/device/K950836 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950836: Redfield Infrared Coagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950836
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026