510(k) · Cleared
Recalled · Class II · 2015Sheffield Pharmaceuticals (Sterile) Lubrigel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheffield Industries, Div. of Faria, Ltd. · KMJ Lubricant, Patient
Cleared on May 22, 2008 as substantially equivalent to K041060 (Chester Labs, Inc., 2004) and 1 other predicate after a 146-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- May 22, 2008
- Review
- 146 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974768 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK974768 Pdi Sterile Lubricating JellyNice-Pak Products, Inc. · 1998
- This deviceK073684 Sheffield Pharmaceuticals (Sterile) LubrigelSheffield Industries, Div. of Faria, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK101522 Ultra Seal Sterile Lubricating JellyUltra Seal Corporation · 2010
Most influential descendants
Showing 1 of 1 · See all- K101522Ultra Seal Sterile Lubricating JellyUltra Seal Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974768 | Pdi Sterile Lubricating Jelly | Nice-Pak Products, Inc. | 1998 | — |
| 0 (this device) | K073684 | Sheffield Pharmaceuticals (Sterile) Lubrigel | Sheffield Industries, Div. of Faria, Ltd. | 2008 | — |
| +1 | K101522 | Ultra Seal Sterile Lubricating Jelly | Ultra Seal Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K041060 | E-Z Lubricating JellySummary page 4…’s Name: Sheffield Phar;na(iculicfiis Stclji-ic.'lft.zbric-}.c_l e A * Predicated Device(s): . E-Z Lubricating Jelly (St_cnle), manufactured by Chester : £ Labs Inc. (}\041060) g _ ; R -~ PDI Lubricating Jelly (Qlenle) manufactured by N10{.~Pa|\ - .~ 'Products, Inc, (K974768) : - FITNS P ; _17e BROAD… | 2004 |
| * | K974768 | Pdi Sterile Lubricating JellySummary page 4…Lubricating Jelly (St_cnle), manufactured by Chester : £ Labs Inc. (}\041060) g _ ; R -~ PDI Lubricating Jelly (Qlenle) manufactured by N10{.~Pa|\ - .~ 'Products, Inc, (K974768) : - FITNS P ; _17e BROAD STREET, New Lonoon, CT 06320 USA TEL 800 o299 ¢ 1087 FAX 860 442 0356 ' " GENERAL@SHEFFIELD-PHARMACEU… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101522 | Ultra Seal Sterile Lubricating Jelly | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2015 | Class II | Z-1953-2015 | Process control | Recovery of high count of gram positive rods including single colonies of B. cepacia. |
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. 2008, 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?
Patient lubricant intended for medical purposes to lubricate orifices to facilitate the entry of diagnostic and therapeutic devices. The device is intended for use on order of a physician.
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/K073684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073684: Sheffield Pharmaceuticals (Sterile) Lubrigel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073684
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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