510(k) · Cleared

Recalled · 2000

Critikon Soft Blood Pressure Cuff

K974080510(k) TraditionalCleared May 18, 1998201-day reviewClass II21 CFR 870.1120Recalls 1

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

Johnson & Johnson Medical, Inc. · DXQ Blood Pressure Cuff

Cleared on May 18, 1998 as substantially equivalent to K790810 (Crest Medical Equipment, 1979) and 4 other predicates after a 201-day review. Its family tree reaches back 1 generation to 1979. 51 later devices descend from it. It has been recalled once.

Decided: May 18, 1998
Review: 201 days
Class: Class II
Product code: DXQ
Recalls: 1
Predicates: 5

Its longest line of descent runs back 1 generation to K790810 (1979). 5 ancestors in all. 51 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK790810 Disposa-CufCrest Medical Equipment · 1979
This deviceK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998
Descendant · cites it directly · 23 of its ownK120364 Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012
Descendant · cites it directly · 14 of its ownK012194 Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001
Descendant · 2 generations on · 13 of its ownK043286 Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005
Descendant · 3 generations on · 10 of its ownK173246 Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018
Descendant · 4 generations on · 9 of its ownK190902 RH non-Automated Blood Pressure Meter RH non-Automated Blood…Wenzhou Renhua Instruments Co., Ltd. · 2019

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2001high 5 (2023) · low 0 (2002)2026

Most influential descendants

Showing 5 of 51 · See all

K120364Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012 · cites it directly23descendants
K012194Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001 · cites it directly14descendants
K043286Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005 · 2 generations on13descendants
K173246Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018 · 3 generations on10descendants
K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with…Wenzhou Renhua Instruments Co., Ltd. · 2019 · 4 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K790810	Disposa-Cuf	Crest Medical Equipment	1979	—
0 (this device)	K974080	Critikon Soft Blood Pressure Cuff	Johnson & Johnson Medical, Inc.	1998	—
+1	K120364	Unimed Disposable Blood Pressure Cuff	Unimed Medical Supplies, Inc.	2012	—
+1	K012194	Blood Pressure Monitor (Sphygmomanometer), Model HT-110	Nihon Seimitsu Sokki Co., Ltd.	2001	—
+2	K043286	Aneroid Sphygmomanometer, Model BK2002	Wenzhou Bokang Instrument Co.,Ltd	2005	—
+3	K173246	Aneroid Sphygmomanometer	Wenzhou Bokang Instruments Co., Ltd.	2018	—
+4	K190902	RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter…	Wenzhou Renhua Instruments Co., Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1992	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2004	1	0
2005	1	0
2007	1	0
2008	1	0
2009	1	0
2012	3	0
2013	2	0
2014	1	0
2015	3	0
2016	2	0
2017	2	0
2018	4	0
2019	3	0
2020	3	0
2021	3	0
2022	4	0
2023	5	0
2024	2	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K974080, 1979–2026Source: 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 13.3 · 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K790810	Disposa-Cuf Summary page 2 …tly marketed by Johnson & Johnson Medical, Inc. The original DISPOSA-CUF Blood Pressure Cuff received market clearance on May 25, 1979 via Crest Medical Equipment 510(k) K790810. The device is virtually the same as the CRITIKON or DISPOSA-CUF Soft Blood Pressure Cuff. The CRITIKON Soft Blood Pressure Cuff…	Crest Medical Equipment	1979	—
*	K911213	Cuffable Summary page 2 …TIKON Soft Blood Pressure Cuff is also substantially equivalent to the CUFF-ABLE* Blood Pressure Cuff currently marketed by Vital Signs, Inc. [Biomedical Dynamics 510(k) K911213] and other soft blood pressure cuffs. Device Manufacturer 510(k) CRITIKON (formerly Johnson & Johnson K790810 DISPOSA-CUF) Soft…	Biomedical Dynamics, Inc.	1991	1
*	K883977	Surgi-Cuf Sterile/Non-Sterile Disposable Summary page 2 …ressure cuffs. Device Manufacturer 510(k) CRITIKON (formerly Johnson & Johnson K790810 DISPOSA-CUF) Soft Medical, Inc. Blood Pressure Cuff SURGI-CUF* Cuff Ethox Corp. K883977 CUFF-ABLE Cuff Vital Signs, Inc. K911213 Cuff-m* Cuff Lorin Medical K921997 Sofi Check* Cuff Statcorp, Inc. K940214 Safe-Cuff* Cu…	Ethox Corp.	1989	—
*	K921997	CUFF-M Summary page 2 …son K790810 DISPOSA-CUF) Soft Medical, Inc. Blood Pressure Cuff SURGI-CUF* Cuff Ethox Corp. K883977 CUFF-ABLE Cuff Vital Signs, Inc. K911213 Cuff-m* Cuff Lorin Medical K921997 Sofi Check* Cuff Statcorp, Inc. K940214 Safe-Cuff* Cuff CAS Medical Systems Unknown The device comprises tubing attached to a so…	Lorin Medical, Inc.	1992	—
*	K940214	Statcorp Inc. Disposable Blood Pressure Cuff Summary page 2 …nc. Blood Pressure Cuff SURGI-CUF* Cuff Ethox Corp. K883977 CUFF-ABLE Cuff Vital Signs, Inc. K911213 Cuff-m* Cuff Lorin Medical K921997 Sofi Check* Cuff Statcorp, Inc. K940214 Safe-Cuff* Cuff CAS Medical Systems Unknown The device comprises tubing attached to a soft inelastic sleeve with-an _ integrated…	Statcorp, Inc.	1994	—
*	—	Safe-Cuff Cuff Named without a submission number			—

Also cleared against K790810: 2 other devices →

What descends from it? (51)

See all 51

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120364	Unimed Disposable Blood Pressure Cuff	Unimed Medical Supplies, Inc.	2012	23
K012194	Blood Pressure Monitor (Sphygmomanometer), Model HT-110	Nihon Seimitsu Sokki Co., Ltd.	2001	14
K120125	Soft-Cuf, Classic-Cuf, Dura-Cuf, Sensa-Cuf	Ge Medical Systems Information Technologies, Inc.	2012	3
K070060	Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood…	Welch Allyn, Inc.	2007	2
K130942	Legacy Medical Eco-Choice Disposable Blood Pressure Cuff	Legacy Medical, Inc.	2013	0
K092999	NBP Cuff	Draeger Medical AG & Co. KG	2009	0
K080854	Disposable Blood Pressure Cuff, Model DC100	Suntech Medical, Inc.	2008	0
K040410	Greenlight 300	A C Cossor & Son (Surgical) Limited	2004	0
K032821	Hygia Health Services Reprocessed Blood Pressure Cuff	Hygia Health Services, Inc.	2003	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 24, 2000	Not classified	Z-1236-03	Other	Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K120364 (Unimed Medical Supplies, Inc., 2012) has gone furthest, with 23 descendants of its own.
2 other devices also cite its predicate K790810.

How does its category compare?

All DXQ devices

DXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and semi-disposable (may be single-patient use or optional limited reuse). It is available in neonatal, pediatric and adult sizes. The device is not designed, sold, or intended for use except as indicated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974080 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974080: Critikon Soft 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/K974080

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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