# K080042: Spirus Medical Surgical Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Spirus Medical, Inc.
- Decided: Apr 3, 2008 after 86 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810310 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810310: K-Y Lubricating Jelly, Johnson & Johnson Professionals, Inc. (1981) Summary page 1.
- K952464: Probe Personal Lubricant - Classic, Davryan Laboratories, Inc. (1995) Summary page 1.

## Indications for use
Intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices.

Source page: https://510kreport.com/device/K080042
Methodology: https://510kreport.com/methodology