# K982891: California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands

- Pathway: 510(k) (Traditional)
- Applicant: California Medical Laboratories, Inc.
- Decided: Sep 30, 1998 after 44 days
- Product code: DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4420
- Recalls of this device: 10 (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. The FDA summary names its predicate without a number.
- (no number) Research Medical, Inc. Rigid Intracardiac Suction Wand: named in the summary without a submission number

## Most influential descendants
- K053021: Estech Clearview MV Atrial Depressor (2006), 0 descendants of its own

## Recalls of this device
- Nov 2, 2012 · Class II · Z-0649-2013: California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand an
- Nov 2, 2012 · Class II · Z-0650-2013: California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand an
- Feb 5, 2008 · Not classified · Z-2046-2009: A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
- Jan 29, 2008 · Not classified · Z-1311-2008: Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining i
- Jan 29, 2008 · Not classified · Z-1312-2008: Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining i
- Jan 29, 2008 · Not classified · Z-1310-2008: Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining i
- Jan 29, 2008 · Not classified · Z-1313-2008: Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining i
- Jan 24, 2008 · Not classified · Z-1175-2008: Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
- Jan 24, 2008 · Not classified · Z-1176-2008: Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
- Jan 24, 2008 · Not classified · Z-1177-2008: Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

## Indications for use
The Standard and Small Rigid Tip Suction Wands are indicated for use to remove excess fluid from the surgical field.

Source page: https://510kreport.com/device/K982891
Methodology: https://510kreport.com/methodology