# K900815: Sarns 9000 Perfusion System W/Alert Only Level

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: May 9, 1990 after 77 days
- Product code: DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4340
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jan 12, 2007 · Not classified · Z-0657-2007: The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Sum
- Jan 12, 2007 · Not classified · Z-0659-2007: The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Sum
- Jan 12, 2007 · Not classified · Z-0655-2007: The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Sum
- Jan 12, 2007 · Not classified · Z-0656-2007: The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Sum
- Jan 12, 2007 · Not classified · Z-0658-2007: The hand crank may crack in the bearing/shaft area due to a manufacturing defect. (Note: Some of the hand cranks subject to this recall were shipped as replacements for hand cranks recalled in the Sum
- Sep 14, 2006 · Not classified · Z-0233-2007: The hand crank handle may separate and detach from the unit during use.
- Sep 14, 2006 · Not classified · Z-0235-2007: The hand crank handle may separate and detach from the unit during use.
- Sep 14, 2006 · Not classified · Z-0234-2007: The hand crank handle may separate and detach from the unit during use.

Source page: https://510kreport.com/device/K900815
Methodology: https://510kreport.com/methodology