510(k) · Cleared

Cleared

pjur WOMAN Nude pjur med SENSITIVE glide

K200730510(k) TraditionalCleared Dec 17, 2020272-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

Pjur Group Luxembourg S.A. · NUC Lubricant, Personal

Cleared on Dec 17, 2020 as substantially equivalent to K201186 (Rb Health (Us), LLC, 2020) after a 272-day review. Its family tree reaches back 2 generations to 2019.

Decided: Dec 17, 2020
Review: 272 days
Class: Class II
Product code: NUC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K183302 (2019). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK183302 KY Banksy AloeRb Health (Us), LLC · 2019
1 generation backK201186 KY Grosz JellyRb Health (Us), LLC · 2020 · Recalled
This deviceK200730 pjur WOMAN Nude pjur med SENSITIVE glidePjur Group Luxembourg S.A. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K183302	KY Banksy Aloe	Rb Health (Us), LLC	2019	—
−1	K201186	KY Grosz Jelly	Rb Health (Us), LLC	2020	1
0 (this device)	K200730	pjur WOMAN Nude pjur med SENSITIVE glide	Pjur Group Luxembourg S.A.	2020	—

FIG. 1 — Lineage of K200730, 2019–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K201186	KY Grosz Jelly Cleared while this submission was under review Summary page 4 …Condom PRODUCT CODE: NUC (Lubricant, Personal) DEVICE CLASS: 2 PREDICATE DEVICE: KY Grosz Jelly, K201186 The predicate device has not been subject to a design- rel…	Rb Health (Us), LLC	2020	1

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?

The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 1.3 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All NUC devices

NUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · NUC

11in 2025

2007high 21 (2015) · low 2 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUC

221in 2025

2007high 271 (2008) · low 112 (2022)2026

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

Recalls per year · NUC

3in 2013

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	150	0	0
2008	7	271	1	6
2009	2	—	1	13
2010	4	124	0	2
2011	2	—	0	3
2012	6	269	0	6
2013	11	205	3	5
2014	11	264	0	14
2015	21	251	0	8
2016	14	181	0	14
2017	14	175	0	19
2018	15	114	0	6
2019	13	150	0	8
2020	19	180	0	2
2021	20	143	0	7
2022	14	112	0	7
2023	13	159	0	15
2024	6	178	0	13
2025	11	221	0	13
2026	12	104	0	—

What is it indicated for?

pjur® med SENSITIVE glide for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

pjur® WOMAN Nude for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200730 · printed Nov 3, 2026

Cite this page

510(k) Report. “K200730: pjur WOMAN Nude pjur med SENSITIVE glide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200730

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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