510(k) Report

510(k) · Cleared

Cleared

Personal Warming Gel

K050211510(k) TraditionalCleared Mar 17, 200545-day reviewClass II21 CFR 884.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Qualis, Inc. · NUC Lubricant, Personal

Cleared on Mar 17, 2005 as substantially equivalent to K040340 (Personal Products Company, Div. of Mcneil-Ppc, Inc., 2004) after a 45-day review. Its family tree reaches back 1 generation to 2004.

Decided
Mar 17, 2005
Review
45 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K040340 (2004). No later device cites it as a predicate yet.

K040340 · K-Y Brand Warming Ultragel Personal Lubricant · Personal Products Company, Div. of Mcneil-Ppc, Inc. · 20042000200220042006
K040340 · K-Y Brand Warming Ultragel Personal Lubricant · Personal Products Company, Div. of Mcneil-Ppc, Inc. · 20040
  1. Root · 1 generation backK040340 K-Y Brand Warming Ultragel Personal LubricantPersonal Products Company, Div. of Mcneil-Ppc, Inc. · 2004
  2. This deviceK050211 Personal Warming GelQualis, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K040340K-Y Brand Warming Ultragel Personal LubricantPersonal Products Company, Div. of Mcneil-Ppc, Inc.2004—
0 (this device)K050211Personal Warming GelQualis, Inc.2005—
FIG. 1 — Lineage of K050211, 2004–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NUC? 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 NUC device

  1. #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K040340K-Y Brand Warming Ultragel Personal Lubricant
Summary page 1
…afety and Effectiveness A. Legally Marketed Device. Qualis claims substantial equivalence to K-Y Warming Ultra Gel Personal Lubricant (K040340), currently in commercial distribution by Personal Products Company Division of McNeil-PPC inc.. B. D…
Personal Products Company, Div. of Mcneil-Ppc, Inc.2004—

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?

  • Its one ancestor has no recall.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUC

11in 2025

2007: 52008: 72009: 22010: 42011: 22012: 62013: 112014: 112015: 212016: 142017: 142018: 152019: 132020: 192021: 202022: 142023: 132024: 62025: 112026 (partial year): 12
2007high 21 (2015) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUC

221in 2025

2007: 150 days median2008: 271 days median2010: 124 days median2012: 269 days median2013: 205 days median2014: 264 days median2015: 251 days median2016: 181 days median2017: 175 days median2018: 114 days median2019: 150 days median2020: 180 days median2021: 143 days median2022: 112 days median2023: 159 days median2024: 178 days median2025: 221 days median2026 (partial year): 104 days median
2007high 271 (2008) · low 112 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NUC

3in 2013

2008: 12009: 12013: 3
2007high 3 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NUC

13in 2025

2008: 62009: 132010: 22011: 32012: 62013: 52014: 142015: 82016: 142017: 192018: 62019: 82020: 22021: 72022: 72023: 152024: 132025: 13
2007high 19 (2017) · low 0 (2007)2025

MAUDE reports naming product code NUC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007515000
2008727116
20092—113
2010412402
20112—03
2012626906
20131120535
201411264014
20152125108
201614181014
201714175019
20181511406
20191315008
20201918002
20212014307
20221411207
202313159015
20246178013
202511221013
2026121040—

What is it indicated for?

Personal Warming Gel is designed to enhance the ease and comfort of

intimate activity and is compatible with latex condoms

Indications for use as stated in the FDA summary.

More from Qualis, Inc.

6 FDA decisions under this applicant name. See the company

  • K050212Personal Warming JellyQualis, Inc. · 2005
  • K041129Personal Lubricating GelQualis, Inc. · 2004
  • K040085Personal Warming LubricantQualis, Inc. · 2004
  • K973780Personal Lubricating LiquidQualis, Inc. · 1997
  • K973557LubriglideQualis, Inc. · 1997

Recent decisions in NUC

The NUC category page

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  • K261905BUM OilBumlicious, LLC (DBA “Bumlicious”) · 2026
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https://510kreport.com/device/K050211 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050211: Personal Warming Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050211

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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