510(k) Report

510(k) · Cleared

Cleared

Lubricating Jelly

K903910510(k) TraditionalCleared Oct 26, 199064-day reviewClass I21 CFR 880.6375

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

Lake Pharmaceutical, Inc. · KMJ Lubricant, Patient

Cleared on Oct 26, 1990 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Oct 26, 1990
Review
64 days
Class
Class I
Product code
KMJ
Recalls
None
Predicates
0

19 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2004: 1 descendant cleared2006: 2 descendants cleared2015: 2 descendants cleared2023: 2 descendants cleared2016: 1 descendant cleared2021: 4 descendants cleared2017: 1 descendant cleared2019: 2 descendants cleared2020: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK903910 Lubricating JellyLake Pharmaceutical, Inc. · 1990
  2. Descendant · cites it directly · 18 of its ownK982673 Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998
  3. Descendant · 2 generations on · 17 of its ownK033776 Instead Intimate LubricantInstead, Inc. · 2004
  4. Descendant · 3 generations on · 15 of its ownK051295 I-D GlideWestridge Laboratories, Inc. · 2006
  5. Descendant · 4 generations on · 12 of its ownK150480 JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015
  6. Descendant · 5 generations on · 9 of its ownK160211 Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1998: 12004: 12006: 22015: 22016: 12017: 12019: 22020: 22021: 42023: 22025: 1
1998high 4 (2021) · low 0 (1999)2026

Most influential descendants

Showing 5 of 19 · See all
  • K982673Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic · 1998 · cites it directly18descendants
  • K033776Instead Intimate LubricantInstead, Inc. · 2004 · 2 generations on17descendants
  • K051295I-D GlideWestridge Laboratories, Inc. · 2006 · 3 generations on15descendants
  • K150480JO H20 Water Based Personal LubricantUnited Consortium, Inc. · 2015 · 4 generations on12descendants
  • K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International · 2016 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903910Lubricating JellyLake Pharmaceutical, Inc.1990—
+1K982673Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic1998—
+2K033776Instead Intimate LubricantInstead, Inc.2004—
+3K051295I-D GlideWestridge Laboratories, Inc.2006—
+4K150480JO H20 Water Based Personal LubricantUnited Consortium, Inc.2015—
+5K160211Wet Original Personal LubricantTrigg Laboratories D/B/A Wet International2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200620
201520
201610
201710
201920
202020
202140
202320
202510
FIG. 1 — Lineage of K903910, 1990–2025Source: 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), 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
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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? (19)

See all 19

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982673Just Between US, Personal Lubricant & CondomKey West Fragrance & Cosmetic199818

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, K982673 (Key West Fragrance & Cosmetic, 1998) has gone furthest, with 18 descendants of its own.

How does its category compare?

All KMJ devices

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

FDA decisions per year · KMJ

1in 2015

2008: 32009: 12010: 12011: 12012: 32013: 12014: 12015: 1
2007high 3 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMJ

141in 2012

2008: 86 days median2012: 141 days median
2007high 141 (2012) · low 86 (2008)2026

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

Recalls per year · KMJ

1in 2016

2010: 12011: 122016: 1
2007high 12 (2011) · low 0 (2007)2026

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

Adverse event reports per year · KMJ

1in 2025

2007: 52008: 32009: 12010: 12011: 72012: 22013: 62014: 22015: 42016: 52017: 12018: 52019: 22020: 12022: 42023: 42024: 32025: 1
2007high 7 (2011) · low 0 (2021)2025

MAUDE reports naming product code KMJ, 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
20070—05
200838603
20091—01
20101—11
20111—127
2012314102
20131—06
20141—02
20151—04
20160—15
20170—01
20180—05
20190—02
20200—01
20210—00
20220—04
20230—04
20240—03
20250—01
20260—0—
Cite this page

510(k) Report. “K903910: Lubricating Jelly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903910

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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