# K921048: BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst

- Pathway: 510(k) (Traditional)
- Applicant: Colin Medical Instruments Corp.
- Decided: Jul 1, 1993 after 484 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
102 later devices descend from it; 4 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973637: Press-Mate Advantage (1998), 101 descendants of its own
- K022537: Press-Mate PM-2100 Vital Sign Monitor (2002), 50 descendants of its own
- K013434: VP-2000/1000 (2002), 46 descendants of its own
- K071645: Model HBP T-105 Series, Model T-105 and T-105S (2007), 28 descendants of its own
- K082357: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office (TWIN200). (2008), 27 descendants of its own

Source page: https://510kreport.com/device/K921048
Methodology: https://510kreport.com/methodology