# K990447: 1000 Pressure Infusion Sigmacon 1000

- Pathway: 510(k) (Traditional)
- Applicant: Valley West, Inc.
- Decided: May 12, 1999 after 89 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K800560 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800560: MX820-5 Pressure Infusor 500CC MX820-10, Medex, Inc. (1980) Summary page 2.
- K953574: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer, American Hydro-Surgical Instruments, Inc. (1995) Summary page 2.
- K822286: Autocuff (Photos Enclosed with 510K, Partamed, Inc. (1982). Our OCR of the scanned summary read K922286, FDA’s number for Model XCT-900 PQCT X-Ray Bone Densitometer (Norland Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Automatic Surgical Irrigation Pump/Autocuff”.
- K924530: Cabot Medical Niagara (TM) 3.0 Liter High Flow Irri, Cabot Medical Corp. (1993) Summary page 2.
- K973133: Big Bag 3000 Pressure Infusor, Byron Medical (1997) Summary page 2.
- K980089: 3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000, Valley West, Inc. (1998) Summary page 2.

## Indications for use
The 1000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

Source page: https://510kreport.com/device/K990447
Methodology: https://510kreport.com/methodology