510(k) · Cleared
ClearedLubricating Jelly, Low Viscosity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Span-America Medical Systems, Inc. · KMJ Lubricant, Patient
Cleared on Jul 18, 1996 as substantially equivalent to K882506 (Span-America Medical Systems, Inc., 1988) after a 90-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jul 18, 1996
- Review
- 90 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K882506 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK882506 Modified American Lubricating Jelly, 2.7 & 5.0Span-America Medical Systems, Inc. · 1988
- This deviceK961502 Lubricating Jelly, Low ViscositySpan-America Medical Systems, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882506 | Modified American Lubricating Jelly, 2.7 & 5.0 | Span-America Medical Systems, Inc. | 1988 | — |
| 0 (this device) | K961502 | Lubricating Jelly, Low Viscosity | Span-America Medical Systems, Inc. | 1996 | — |
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 |
|---|---|---|---|
| * | K882506 | Modified American Lubricating Jelly, 2.7 & 5.0Summary page 1…SSIFICATION NAME: PREDICATE DEVICE: DESCRIPTION: INDICATIONS FOR USE: SUBSTANTIAL EQUIVALENCE: WPWINW. TOTTON\LUBES10K.C96 Lubricant, Patient Lubricating Jelly, S10K882506 Lubricating Jelly is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate e… | 1988 |
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?
- Its one ancestor has no recall.
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?
To lubricaie a budy vrifice to facilitate catry of a diagnostic or therapeutic device.
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/K961502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961502: Lubricating Jelly, Low Viscosity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961502
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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