510(k) · Cleared
ClearedUltra Seal Sterile Lubricating Jelly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultra Seal Corporation · KMJ Lubricant, Patient
Cleared on Dec 23, 2010 as substantially equivalent to K871169 (H & P Industries, Inc., 1987) and 1 other predicate after a 204-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Dec 23, 2010
- Review
- 204 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974768 (1998). 4 ancestors in all, the oldest K871169 (1987). No later device cites it as a predicate yet.
- Root · 2 generations backK974768 Pdi Sterile Lubricating JellyNice-Pak Products, Inc. · 1998
- 1 generation backK073684 Sheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria, Ltd. · 2008 · Recalled
- This deviceK101522 Ultra Seal Sterile Lubricating JellyUltra Seal Corporation · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974768 | Pdi Sterile Lubricating Jelly | Nice-Pak Products, Inc. | 1998 | — |
| −1 | K073684 | Sheffield Pharmaceuticals (Sterile) Lubrigel | Sheffield Industries, Div. of Faria, Ltd. | 2008 | 1 |
| 0 (this device) | K101522 | Ultra Seal Sterile Lubricating Jelly | Ultra Seal Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K871169 | Lubricating JellySummary page 1…al .New Device's Name: Ultra. Seal Sterile Lubricating Jelly Predicated Device(s): Triad Lubricating Jelly, Manufactured by HP Industries Originally, (K871169) Sheffield Pharmaceuticals Sterile Lubrigel, Manufactured by Sheffield Pharmaceuticals, Inc. (K073684), Inf… | 1987 |
| * | K073684 | Sheffield Pharmaceuticals (Sterile) LubrigelSummary page 1…g Jelly, Manufactured by HP Industries Originally, (K871169) Sheffield Pharmaceuticals Sterile Lubrigel, Manufactured by Sheffield Pharmaceuticals, Inc. (K073684), Information supporting claims of substantial equivalence, as defined under the Federal Food Drug * and Cosmetic Act, w… | 2008 |
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 12 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K871169.
How does its category compare?
All KMJ devicesKMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices. The device is intended for use on order of a physician.
For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101522: Ultra Seal 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/K101522
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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