# K870572: Arrow-Clarke (TM) Pleura-Seal (TM) Thoracentesis Kit

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: May 26, 1987 after 105 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: 2 (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
- K964519: Curity Thoracentesis Tray (1996), 0 descendants of its own

## Recalls of this device
- Apr 11, 2018 · Class II · Z-1966-2018: Product sterility may be compromised due to unsealed packaging.
- Oct 24, 2017 · Class II · Z-1298-2018: Product packaging may not be completely sealed.

Source page: https://510kreport.com/device/K870572
Methodology: https://510kreport.com/methodology