# K832755: Infusion Pump & IV Sets #4000

- Pathway: 510(k) (Traditional)
- Applicant: Omni-Glow, Inc.
- Decided: Nov 3, 1983 after 79 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 16 (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
- K033576: Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure (2003), 0 descendants of its own

## Recalls of this device
- Nov 24, 2009 · Not classified · Z-1356-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1353-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1352-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1354-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1355-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1358-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1357-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1341-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1351-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Jan 9, 2006 · Not classified · Z-0505-06: The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
- Jun 9, 2003 · Not classified · Z-0955-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0958-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0959-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- Jun 9, 2003 · Not classified · Z-0957-03: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
- May 13, 2003 · Not classified · Z-0936-03: The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
- May 13, 2003 · Not classified · Z-0915-03: IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

Source page: https://510kreport.com/device/K832755
Methodology: https://510kreport.com/methodology