510(k) · Cleared
Recalled · Class II · 2022Dynarex Sterile Lubricating Jelly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynarex Corporation · KMJ Lubricant, Patient
Cleared on Dec 18, 2009 as substantially equivalent to K041060 (Chester Labs, Inc., 2004) after a 127-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 18, 2009
- Review
- 127 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041060 (2004). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK041060 E-Z Lubricating JellyChester Labs, Inc. · 2004 · Recalled
- This deviceK092488 Dynarex Sterile Lubricating JellyDynarex Corporation · 2009
- Descendant · cites it directly · 0 of its ownK142473 Lubricating JellySion Biotext Medical, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK113689 Dukal Lubricating JellyDukal Corporation · 2012
- Descendant · cites it directly · 0 of its ownK112110 Sterile Lubricating JellyJianerkang Medical Dressing Company · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041060 | E-Z Lubricating Jelly | Chester Labs, Inc. | 2004 | 1 |
| 0 (this device) | K092488 | Dynarex Sterile Lubricating Jelly | Dynarex Corporation | 2009 | — |
| +1 | K142473 | Lubricating Jelly | Sion Biotext Medical, Ltd. | 2015 | — |
| +1 | K113689 | Dukal Lubricating Jelly | Dukal Corporation | 2012 | — |
| +1 | K112110 | Sterile Lubricating Jelly | Jianerkang Medical Dressing Company | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
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 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
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 | Decided |
|---|---|---|---|
| * | K041060 | E-Z Lubricating JellySummary page 1…rex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available. Predicate Device: E-Z Lubricating Jerry, 510Ok Number K041060 is manufactured by Chester Labs, Inc. 1900 Section Rd., Cincinnati, OH 45237. Substantial Equivalence: The Dynarex Sterile Lubri… | 2004 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1635-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KMJ devicesKMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KMJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KMJ
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KMJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMJ
1in 2025
MAUDE reports naming product code KMJ, 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 | 0 | — | 0 | 5 |
| 2008 | 3 | 86 | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 1 | 1 |
| 2011 | 1 | — | 12 | 7 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 1 | 5 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092488: Dynarex Sterile 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/K092488
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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