510(k) · Cleared
ClearedSpirus Medical Surgical Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirus Medical, Inc. · KMJ Lubricant, Patient
Cleared on Apr 3, 2008 as substantially equivalent to K810310 (Johnson & Johnson Professionals, Inc., 1981) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Apr 3, 2008
- Review
- 86 days
- Class
- Class I
- Product code
- KMJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810310 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- This deviceK080042 Spirus Medical Surgical InstrumentSpirus Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| 0 (this device) | K080042 | Spirus Medical Surgical Instrument | Spirus Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K810310 | K-Y Lubricating JellySummary page 1…KMJ FDA Regulation: 21 CFR 880.6375 - Patient Lubricant Device Classification: Class I Premarket Notification: K810310 Trade Name: Probe Personal Lubricant (Davryan Laboratories, Inc.) Common/Usual Name:… | 1981 |
| * | K952464 | Probe Personal Lubricant - ClassicSummary page 1…HIS FDA Regulation: 21 CFR 884.5300 - Condom Device Classification: Class II Premarket Notification: K952464 Device Description The Spirus Medical Lubricant is a water-based lubricant intended for lubrication of a body orifice t… | 1995 |
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?
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K810310.
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?
Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080042 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080042: Spirus Medical Surgical Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080042
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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