510(k) · Cleared

Recalled · Class II · 2022

KY Grosz Jelly

K201186510(k) TraditionalCleared Jul 30, 202090-day reviewClass II21 CFR 884.5300Recalls 1

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

Rb Health (Us), LLC · NUC Lubricant, Personal

Cleared on Jul 30, 2020 as substantially equivalent to K183302 (Rb Health (Us), LLC, 2019) after a 90-day review. Its family tree reaches back 1 generation to 2019. 1 later device descends from it. It has been recalled once.

Decided: Jul 30, 2020
Review: 90 days
Class: Class II
Product code: NUC
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K183302 (2019). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK183302 KY Banksy AloeRb Health (Us), LLC · 2019
This deviceK201186 KY Grosz JellyRb Health (Us), LLC · 2020
Descendant · cites it directly · 0 of its ownK200730 pjur WOMAN Nude pjur med SENSITIVE glidePjur Group Luxembourg S.A. · 2020

Most influential descendants

Showing 1 of 1 · See all

K200730pjur WOMAN Nude pjur med SENSITIVE glidePjur Group Luxembourg S.A. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K201186, 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
*	K183302	KY Banksy Aloe Summary page 4 …nt, Personal) Regulatory Class: Class II Predicate Device(s): KY Banksy Aloe RB Health (US) LLC 510(k) No.: K183302 The predicate device has not been subject to a design-related recall. Description of the Device: KY Grosz Jelly is a water-base…	Rb Health (Us), LLC	2019	—

Also cleared against K183302: 4 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K200730	pjur WOMAN Nude pjur med SENSITIVE glide	Pjur Group Luxembourg S.A.	2020	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 23, 2022	Class II	Z-1547-2022	Storage	Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K200730 (Pjur Group Luxembourg S.A., 2020) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K183302.

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?

This product is intended for penile, vaginal and/or anal application 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 polyisoprene condoms. This product is not compatible with polyurethane condoms.

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/K201186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201186: KY Grosz Jelly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201186

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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