# K253964: Disposable Neonatal NIBP Cuff (U1681S-C51N)

- Pathway: 510(k) (Special)
- Applicant: Unimed Medical Supplies, Inc.
- Decided: Jan 9, 2026 after 29 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K790810 (1979). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251045: Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N), Unimed Medical Supplies, Inc. (2025) Summary page 5.

## Indications for use
The Unimed disposable blood pressure cuff (Models U1681S-C51N to U1685S-C51N) is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is non-sterile and for single-patient use. The cuff is available in neonatal sizes (3–15 cm limb circumference). The cuff is not designed, sold, or intended for use except as indicated.

Source page: https://510kreport.com/device/K253964
Methodology: https://510kreport.com/methodology