510(k) · Cleared

Cleared

Hygia Health Services Reprocessed Blood Pressure Cuff

K032821510(k) TraditionalCleared Dec 5, 200391-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

Hygia Health Services, Inc. · NPP Reprocessed Blood Pressure Cuff

Cleared on Dec 5, 2003 as substantially equivalent to K974080 (Johnson & Johnson Medical, Inc., 1998) and 6 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1979.

Decided: Dec 5, 2003
Review: 91 days
Class: Class II
Product code: NPP
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K790810 (1979). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
1 generation backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
This deviceK032821 Hygia Health Services Reprocessed Blood Pressure CuffHygia Health Services, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K790810	Disposa-Cuf	Crest Medical Equipment	1979	—
−1	K974080	Critikon Soft Blood Pressure Cuff	Johnson & Johnson Medical, Inc.	1998	1
0 (this device)	K032821	Hygia Health Services Reprocessed Blood Pressure Cuff	Hygia Health Services, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1992	1	0
1994	2	0
2000	1	0

FIG. 1 — Lineage of K032821, 1979–2003Source: 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 NPP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (7)

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
*	K974080	Critikon Soft Blood Pressure Cuff Summary page 1 …Devices Device Manufacturer 510(k) Critikon Soft Blood Johnson and Johnson K974080 Pressure Cuff Disposa-Cuff® blood Crest Medical Equipment K790810 pressure cuff…	Johnson & Johnson Medical, Inc.	1998	1
*	K790810	Disposa-Cuf Summary page 1 …Critikon Soft Blood Johnson and Johnson K974080 Pressure Cuff Disposa-Cuff® blood Crest Medical Equipment K790810 pressure cuff Surgi-Cuff® Ethox Corporation K883977 CUFF-ABLE® Cuff…	Crest Medical Equipment	1979	—
*	K883977	Surgi-Cuf Sterile/Non-Sterile Disposable Summary page 1 …Disposa-Cuff® blood Crest Medical Equipment K790810 pressure cuff Surgi-Cuff® Ethox Corporation K883977 CUFF-ABLE® Cuff Vital Signs, Inc. K91 1213 (B io-Med…	Ethox Corp.	1989	—
*	K911213	Cuffable Summary page 1 …pressure cuff Surgi-Cuff® Ethox Corporation K883977 CUFF-ABLE® Cuff Vital Signs, Inc. K91 1213 (B io-Medical Dynamics) Statcorp Disposable Blood Statcorp, Incorporated…	Biomedical Dynamics, Inc.	1991	1
*	K940214	Statcorp Inc. Disposable Blood Pressure Cuff Summary page 1 …Signs, Inc. K91 1213 (B io-Medical Dynamics) Statcorp Disposable Blood Statcorp, Incorporated K940214 Pressure Cuff ______________ Technicuff® TECHNICUFF CORP. K9…	Statcorp, Inc.	1994	—
*	K942259	Technicuff Summary page 1 …Statcorp, Incorporated K940214 Pressure Cuff ______________ Technicuff® TECHNICUFF CORP. K942259 Cloud Cuff®g Parts Port, Ltd K002360 4. Device Description Per CFR 870.…	Technicuff Corp.	1994	—
*	K002360	Cloud Cuff Summary page 1 …______________ Technicuff® TECHNICUFF CORP. K942259 Cloud Cuff®g Parts Port, Ltd K002360 4. Device Description Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder…	Parts Port, Ltd.	2000	—

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

How does its category compare?

All NPP devices

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

FDA decisions per year · NPP

FDA has decided no NPP device since 2007.

Median 510(k) review, days · NPP

Too few NPP 510(k)s in any year since 2007 to give a median.

Recalls per year · NPP

No recall names NPP since 2007.

Adverse event reports per year · NPP

1in 2024

2007high 1 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	1
2020	—	1
2021	—	1
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

What is it indicated for?

The Hygia Health Services Reprocessed Blood Pressure Cuff is an accessory used by trained personnel in conjunction with non-invasive blood pressure measurement systems, primarily in a clinical setting.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032821: Hygia Health Services Reprocessed 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/K032821

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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