# K882724: Microtek Probe Drape

- Pathway: 510(k) (Traditional)
- Applicant: Microbio-Medics, Inc.
- Decided: Aug 3, 1988 after 33 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970891: Drape, Surgical-Latex (1997), 0 descendants of its own

## Recalls of this device
- Nov 30, 2016 · Class III · Z-0753-2017: The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shippe
- Jul 12, 2013 · Class II · Z-0974-2014: No endotoxin (LAL) testing to proper level.
- Jul 2, 2013 · Class II · Z-0944-2014: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
- Jul 2, 2013 · Class II · Z-0945-2014: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
- Jul 2, 2013 · Class II · Z-0946-2014: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
- Jul 2, 2013 · Class II · Z-0947-2014: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
- Jul 2, 2013 · Class II · Z-0943-2014: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
- Jul 2, 2013 · Class II · Z-0948-2014: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

Source page: https://510kreport.com/device/K882724
Methodology: https://510kreport.com/methodology