510(k) · Cleared

Cleared

Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S & HD-2000F

K983855510(k) TraditionalCleared Nov 17, 199815-day reviewClass II21 CFR 870.1130

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

Jawon Medical Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Nov 17, 1998 as substantially equivalent to K895429 (A&D Engineering, Inc., 1989) after a 15-day review. Its family tree reaches back 1 generation to 1989.

Decided: Nov 17, 1998
Review: 15 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K895429 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK895429 A&D Automatic Digital Blood Pressure Meter 2650A&D Engineering, Inc. · 1989
This deviceK983855 Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S &…Jawon Medical Co., Ltd. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K895429	A&D Automatic Digital Blood Pressure Meter 2650	A&D Engineering, Inc.	1989	—
0 (this device)	K983855	Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S & HD-2000F	Jawon Medical Co., Ltd.	1998	—

FIG. 1 — Lineage of K983855, 1989–1998Source: 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 DXN? 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 DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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
*	K895429	A&D Automatic Digital Blood Pressure Meter 2650 Summary page 1 …Monitor Common Name and Classiﬁcation Name: Noninvasive Blood Pressure Measurement System, 74 DXN 3. PREDICATE DEVICE. A&D Model TM-2650 Automatic Blood Pressure Meter, K895429, SE decision 11/28/89. 4. DEVICE DESCRIPTION. General: Both models of the Jawon system are compact, automatic sphygmomanometers…	A&D Engineering, Inc.	1989	—

Also cleared against K895429: 1 other device →

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.
1 other device also cites its predicate K895429.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, 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	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

What is it indicated for?

Noninvasive measurement of systolic and diastolic blood pressure and

heart rate in adult patients, i.e., age 15 and above, in a home care environment.

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/K983855 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983855: Fuzzy Type Digital Blood Pressure Monitor, Model #'S HD-1000S & HD-2000F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983855

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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