510(k) · Cleared
ClearedPdi Sterile Lubricating Jelly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nice-Pak Products, Inc. · KMJ Lubricant, Patient
Cleared on Jan 16, 1998 after a 25-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jan 16, 1998
- Review
- 25 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK974768 Pdi Sterile Lubricating JellyNice-Pak Products, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK073684 Sheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria, Ltd. · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK131617 Colonglide (R) LubricantPediatric Pharmaceuticals, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK101522 Ultra Seal Sterile Lubricating JellyUltra Seal Corporation · 2010
Most influential descendants
Showing 3 of 3 · See all- K073684Sheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria, Ltd. · 2008 · cites it directly1descendant
- K131617Colonglide (R) LubricantPediatric Pharmaceuticals, Inc. · 2013 · cites it directly0descendants
- K101522Ultra Seal Sterile Lubricating JellyUltra Seal Corporation · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974768 | Pdi Sterile Lubricating Jelly | Nice-Pak Products, Inc. | 1998 | — |
| +1 | K073684 | Sheffield Pharmaceuticals (Sterile) Lubrigel | Sheffield Industries, Div. of Faria, Ltd. | 2008 | 1 |
| +1 | K131617 | Colonglide (R) Lubricant | Pediatric Pharmaceuticals, Inc. | 2013 | — |
| +2 | K101522 | Ultra Seal Sterile Lubricating Jelly | Ultra Seal Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K073684 (Sheffield Industries, Div. of Faria, Ltd., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KMJ devicesKMJ Lubricant, Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
PDI Sterile Lube Jelly is intended for use to lubricant a body orifice of
a patient in order to facilitate the entry of a diagnostic or therapeutic
medical device (such as a catheter, enema tip, or endoscope). The device
is intended for use on order of a physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974768 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974768: Pdi Sterile Lubricating Jelly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974768
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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