510(k) Report

510(k) · Cleared

Cleared

Legacy Medical Eco-Choice Disposable Blood Pressure Cuff

K130942510(k) TraditionalCleared Oct 17, 2013196-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

Legacy Medical, Inc. · DXQ Blood Pressure Cuff

Cleared on Oct 17, 2013 as substantially equivalent to K974080 (Johnson & Johnson Medical, Inc., 1998) and 5 other predicates after a 196-day review. Its family tree reaches back 2 generations to 1979.

Decided
Oct 17, 2013
Review
196 days
Class
Class II
Product code
DXQ
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K790810 (1979). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestors1991: 1 other ancestor1989: 1 other ancestor1992: 1 other ancestorK790810 · Disposa-Cuf · Crest Medical Equipment · 1979K974080 · Critikon Soft Blood Pressure Cuff · Johnson & Johnson Medical, Inc. · 1998 · recalled1980199020002010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K974080 · Critikon Soft Blood Pressure Cuff · Johnson & Johnson Medical, Inc. · 1998 · recalledK790810 · Disposa-Cuf · Crest Medical Equipment · 19790
  1. Root · 2 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
  2. 1 generation backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
  3. This deviceK130942 Legacy Medical Eco-Choice Disposable Blood Pressure CuffLegacy Medical, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K790810Disposa-CufCrest Medical Equipment1979—
−1K974080Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc.19981
0 (this device)K130942Legacy Medical Eco-Choice Disposable Blood Pressure CuffLegacy Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199210
199420
FIG. 1 — Lineage of K130942, 1979–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.3 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K974080Critikon Soft Blood Pressure Cuff
Summary page 1
…ure Cuff Predicate Devices: Device Manufacturer 510(k) Critikon Soft-cuf Blood Pressure Cuff GE Healthcare K974080 Crest Medical Disposa-cuff Blood Pressure Cuff Equipment K(79081…
Johnson & Johnson Medical, Inc.19981
*K790810Disposa-Cuf
Summary page 1
…ure Cuff GE Healthcare K974080 Crest Medical Disposa-cuff Blood Pressure Cuff Equipment K(790810 Surgi-Cuff Ethox Corporation K883977 Cuff-Able Blood Pressure Cuff Vital Signs,…
Crest Medical Equipment1979—
*K883977Surgi-Cuf Sterile/Non-Sterile Disposable
Summary page 1
…Crest Medical Disposa-cuff Blood Pressure Cuff Equipment K(790810 Surgi-Cuff Ethox Corporation K883977 Cuff-Able Blood Pressure Cuff Vital Signs, Inc K911213 Statcorp Disposable Blood Pressure Cuff…
Ethox Corp.1989—
*K911213Cuffable
Summary page 1
…nt K(790810 Surgi-Cuff Ethox Corporation K883977 Cuff-Able Blood Pressure Cuff Vital Signs, Inc K911213 Statcorp Disposable Blood Pressure Cuff Statcorp, Inc K940214 Technicuff…
Biomedical Dynamics, Inc.19911
*K940214Statcorp Inc. Disposable Blood Pressure Cuff
Summary page 1
…le Blood Pressure Cuff Vital Signs, Inc K911213 Statcorp Disposable Blood Pressure Cuff Statcorp, Inc K940214 Technicuff Technicuff Corp. K9422591 Device Description: Per CER 870.1120, a blood pres…
Statcorp, Inc.1994—
*K942259Technicuff
Summary page 1
…p Disposable Blood Pressure Cuff Statcorp, Inc K940214 Technicuff Technicuff Corp. K9422591 Device Description: Per CER 870.1120, a blood pressure cuff is a device that has an inflatable bladder within, or integral to…
Technicuff Corp.1994—

Also cleared against K974080: 8 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?

  • The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K974080.

How does its category compare?

All DXQ devices

DXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DXQ

3in 2025

2007: 22008: 72009: 52010: 22011: 52012: 42013: 22014: 42015: 102016: 42017: 22018: 52019: 32020: 32021: 42022: 42023: 52024: 22025: 32026 (partial year): 4
2007high 10 (2015) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXQ

174in 2025

2008: 118 days median2009: 57 days median2011: 121 days median2012: 102 days median2014: 105 days median2015: 59 days median2016: 217 days median2018: 225 days median2019: 44 days median2020: 207 days median2021: 105 days median2022: 105 days median2023: 79 days median2025: 174 days median2026 (partial year): 102 days median
2007high 225 (2018) · low 44 (2019)2026

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

Recalls per year · DXQ

1in 2025

2011: 12025: 1
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

2007: 32008: 42009: 22010: 12011: 52012: 72013: 92014: 92015: 232016: 502017: 672018: 442019: 412020: 52021: 122022: 32023: 202024: 152025: 20
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—03
2008711804
200955702
20102—01
2011512115
2012410207
20132—09
2014410509
20151059023
20164217050
20172—067
20185225044
2019344041
2020320705
20214105012
2022410503
2023579020
20242—015
20253174120
202641020—

What is it indicated for?

The Legacy Medical Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated:

The Legacy Medical Eco Choice Blood Pressure cuff Is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated.

Indications for use as stated in the FDA summary.

Also cleared against K974080

8 other devices cite the same predicate.

  • K120125Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-CufGe Medical Systems Information Technologies, Inc. · 2012
  • K120364Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012
  • K092999NBP CuffDraeger Medical AG & Co. KG · 2009
  • K080854Disposable Blood Pressure Cuff, Model DC100Suntech Medical, Inc. · 20081 recall
  • K070060Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece)Welch Allyn, Inc. · 20071 recall
  • K040410Greenlight 300A C Cossor & Son (Surgical) Limited · 2004

Recent decisions in DXQ

The DXQ category page

  • K254287Medline Reusable Blood Pressure CuffMedline Industries, LP · 2026
  • K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden Corporation · 2026
  • K253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322…Shenzhen Best Electronics Co., Ltd. · 2026
  • K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc. · 2026
  • K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare Corporation · 2025

https://510kreport.com/device/K130942 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130942: Legacy Medical Eco-Choice Disposable Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130942

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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