510(k) · Cleared

Cleared

Advantage Cuff, Non-Invasive Blood Pressure Hose and Adapter

K063863510(k) TraditionalCleared Mar 20, 200782-day reviewClass II21 CFR 870.1120

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advantage Medical Cables, Inc. · DXQ Blood Pressure Cuff

Cleared on Mar 20, 2007 as substantially equivalent to K022482 (Ge Medical Systems Information Technologies, 2002) after an 82-day review. Its family tree reaches back 1 generation to 2002.

Decided: Mar 20, 2007
Review: 82 days
Class: Class II
Product code: DXQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K022482 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK022482 Sensa-Cuff, Models Infant, Child, AdultGe Medical Systems Information Technologies · 2002
This deviceK063863 Advantage Cuff, Non-Invasive Blood Pressure Hose and AdapterAdvantage Medical Cables, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022482	Sensa-Cuff, Models Infant, Child, Adult	Ge Medical Systems Information Technologies	2002	—
0 (this device)	K063863	Advantage Cuff, Non-Invasive Blood Pressure Hose and Adapter	Advantage Medical Cables, Inc.	2007	—

FIG. 1 — Lineage of K063863, 2002–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXQ device

#1 K254287 Medline Reusable Blood Pressure Cuffscore 13.4 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K022482	Sensa-Cuff, Models Infant, Child, Adult Summary page 1 …fied a legally marketed predicated device of substantial equivalence to the Advantage Cuff, NIBP Hose and Adapter. Sensa®-Cuff, produced by GE® Medical Systems, 510(k) K022482. See Attachment 1. 10630 Wiles Road ·Coral Springs, Florida 33076 · (954) 345-9800 ·(800) 358-2468 ·Fax: (954) 34540507…	Ge Medical Systems Information Technologies	2002	—

Also cleared against K022482: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
5 other devices also cite its predicate K022482.

How does its category compare?

All DXQ devices

DXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DXQ

3in 2025

2007high 10 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXQ

174in 2025

2007high 225 (2018) · low 44 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXQ

1in 2025

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXQ

20in 2025

2007high 67 (2017) · low 1 (2010)2025

MAUDE reports naming product code DXQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	3
2008	7	118	0	4
2009	5	57	0	2
2010	2	—	0	1
2011	5	121	1	5
2012	4	102	0	7
2013	2	—	0	9
2014	4	105	0	9
2015	10	59	0	23
2016	4	217	0	50
2017	2	—	0	67
2018	5	225	0	44
2019	3	44	0	41
2020	3	207	0	5
2021	4	105	0	12
2022	4	105	0	3
2023	5	79	0	20
2024	2	—	0	15
2025	3	174	1	20
2026	4	102	0	—

What is it indicated for?

AMC replacement non-invasive blood pressure cuffs, interface hoses and adapters are accessories for noninvasive blood pressure systems with manual or automated noninvasive sphygmomanometers. The cuffs, interface hoses and adapters are supplied non-sterile and may be reused. The NIEP Cuffs and interface cables are supplied in adult, pediatric, infant and neonatal sizes. The cuffs, interface hoses and adapters are not designed, sold or intended for use except as indicated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063863 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063863: Advantage Cuff, Non-Invasive Blood Pressure Hose and Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063863

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026