510(k) · Cleared
ClearedEvron Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmaceutical Innovations, Inc. · KMJ Lubricant, Patient
Cleared on Jun 26, 1996 after a 90-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.
- Decided
- Jun 26, 1996
- Review
- 90 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 1 citing it directly.
- This deviceK961222 Evron GelPharmaceutical Innovations, Inc. · 1996
- Descendant · cites it directly · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · 2 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- Descendant · 3 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- Descendant · 4 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- Descendant · 5 generations on · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · cites it directly35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 2 generations on34descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 3 generations on33descendants
- K090094Zeltiq SystemZeltiq Aesthetics · 2009 · 4 generations on32descendants
- K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012 · 5 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961222 | Evron Gel | Pharmaceutical Innovations, Inc. | 1996 | — |
| +1 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +2 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| +3 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| +4 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| +5 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 KMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | ULTRA/PHONIC Conductivity Gel and related products (NDC#36-1000-00) Named without a submission number | |
| * | — | ULTRA/PHONIC SG Scanning Gel (NDC#36-1001-00) Named without a submission number | |
| * | — | GAMMA Massage and Ultrasound Gel (NDC#36-1150-00) Named without a submission number |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063715 | Juniper Cooling Device Xtra | 2007 | 35 |
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, K063715 (Juniper Medical, Inc., 2007) has gone furthest, with 35 descendants of its own.
How does its category compare?
All KMJ devicesKMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KMJ
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMJ
1in 2025
MAUDE reports naming product code KMJ, 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 | 0 | — | 0 | 5 |
| 2008 | 3 | 86 | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 1 | — | 12 | 7 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 1 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Submitter’s lubricant is substantially equivalent to, and has the same intended use as, other products in commercial distribution in the United States prior to May 28, 1976. The proposed change to the lubricant consists of expanding the indications for use to specifically include the facilitation of breast self-examination.
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/K961222 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961222: Evron Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961222
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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