# K991525: Deroyal Sterile Neonatal Blood Pressure Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Jul 20, 1999 after 78 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
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. The FDA summary names its predicate without a number.
- (no number) Critikon: named in the summary without a submission number
- (no number) Ethox: named in the summary without a submission number
- (no number) Lorin Medical: named in the summary without a submission number

## Most influential descendants
- K092999: NBP Cuff (2009), 0 descendants of its own

## Indications for use
The DeRoyal Sterile Neonatal Blood Pressure Cuff is indicated for use whenever non-invasive physiologic blood pressure need be obtained from the limbs (extremities) using the appropriate blood pressure monitor designed to operate together with the cuff.

Source page: https://510kreport.com/device/K991525
Methodology: https://510kreport.com/methodology