# K960826: Cadd-Prizm Model 6100 Pump

- Pathway: 510(k) (Traditional)
- Applicant: Sims Deltec, Inc.
- Decided: Aug 23, 1996 after 176 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
6 of 17 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) Abbott Laboratories AIM™ System: named in the summary without a submission number
- (no number) Deltec's CADD-Prizm™ Model 6100 PCS (Pain Control System): named in the summary without a submission number

## Most influential descendants
- K082182: AP 34 Multi-Therapy Infusion Pump (2008), 8 descendants of its own
- K123049: Sapphire Infusion Pump (2013), 7 descendants of its own
- K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software (2013), 7 descendants of its own
- K130394: Cadd -Solis Ambulatory Infusion Pump, Version 3.0 (2013), 4 descendants of its own
- K170982: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) (2017), 3 descendants of its own

## Recalls of this device
- Jan 19, 2007 · Not classified · Z-0718-2007: The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immedia

## Indications for use
The Model 6100 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings.

Source page: https://510kreport.com/device/K960826
Methodology: https://510kreport.com/methodology