510(k) Report

510(k) · Cleared

Cleared

ID Free Personal Lubricant

K240745510(k) TraditionalCleared Sep 27, 2024192-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

Westridge Laboratories, Inc. · NUC Lubricant, Personal

Cleared on Sep 27, 2024 as substantially equivalent to K220653 (Biofilm, Inc., 2022) after a 192-day review. Its family tree reaches back 4 generations to 1981. 1 later device descends from it.

Decided
Sep 27, 2024
Review
192 days
Class
Class II
Product code
NUC
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K810310 (1981). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2026: 1 descendant clearedK810310 · K-Y Lubricating Jelly · Johnson & Johnson Professionals, Inc. · 1981K935299 · Astroglide · Biofilm, Inc. · 1994K072647 · Glycerin & Paraben Free Astroglide · Biofilm, Inc. · 2008K220653 · Astroglide Glycerin & Paraben Free · Biofilm, Inc. · 202219801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 1 descendant K220653 · Astroglide Glycerin & Paraben Free · Biofilm, Inc. · 2022K072647 · Glycerin & Paraben Free Astroglide · Biofilm, Inc. · 2008K935299 · Astroglide · Biofilm, Inc. · 1994K810310 · K-Y Lubricating Jelly · Johnson & Johnson Professionals, Inc. · 19810
  1. Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
  2. 3 generations backK935299 AstroglideBiofilm, Inc. · 1994
  3. 2 generations backK072647 Glycerin & Paraben Free AstroglideBiofilm, Inc. · 2008
  4. 1 generation backK220653 Astroglide Glycerin & Paraben FreeBiofilm, Inc. · 2022
  5. This deviceK240745 ID Free Personal LubricantWestridge Laboratories, Inc. · 2024
  6. Descendant · cites it directly · 0 of its ownK253983 Water-based lubricantGuangzhou Haoyimai Trading Co., Ltd. · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K253983Water-based lubricantGuangzhou Haoyimai Trading Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K810310K-Y Lubricating JellyJohnson & Johnson Professionals, Inc.1981—
−3K935299AstroglideBiofilm, Inc.1994—
−2K072647Glycerin & Paraben Free AstroglideBiofilm, Inc.2008—
−1K220653Astroglide Glycerin & Paraben FreeBiofilm, Inc.2022—
0 (this device)K240745ID Free Personal LubricantWestridge Laboratories, Inc.2024—
+1K253983Water-based lubricantGuangzhou Haoyimai Trading Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K240745, 1981–2026Source: 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
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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
*K220653Astroglide Glycerin & Paraben Free
Summary page 5
…t, Personal) III. Predicate Device Information Proprietary Name: Astroglide® Glycerin & Paraben Free 501(k) number: K220653 Manufacturer: BioFilm Inc. Regulation Name: Condom Regulation Number:…
Biofilm, Inc.2022—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K253983Water-based lubricantGuangzhou Haoyimai Trading Co., Ltd.20260

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?

  • The line of descent spans 43 years and passes through 3 companies; a new generation was cleared every 13.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K253983 (Guangzhou Haoyimai Trading Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

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?

ID Free® Personal Lubricant is for or penile, anal and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and polyisoprenecondoms. This product is not compatible with polyurethane condoms.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K240745: ID Free Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240745

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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