510(k) · Cleared

Cleared

Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY

K033397510(k) TraditionalCleared Apr 9, 2004168-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

Avita Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Apr 9, 2004 as substantially equivalent to K001670 (Omron Healthcare, Inc., 2000) after a 168-day review. Its family tree reaches back 1 generation to 2000. 12 later devices descend from it.

Decided: Apr 9, 2004
Review: 168 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001670 (2000). 12 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
This deviceK033397 Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XYAvita Corporation · 2004
Descendant · cites it directly · 10 of its ownK120675 Digital Automatic Blood Pressure Monitor BPM11 SeriesGrandway Technology (Shenzhen) Limited · 2013
Descendant · 2 generations on · 8 of its ownK133619 Digital Automatic Blood Pressure Monitor BPM18 SeriesGrandway Technology (Shenzhen) Limited · 2014
Descendant · 3 generations on · 3 of its ownK143735 Digital Automatic Blood Pressure Monitor MD2300Grandway Technology (Shenzhen) Limited · 2015
Descendant · 4 generations on · 1 of its ownK163679 Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited · 2017
Descendant · 3 generations on · 1 of its ownK150373 Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model…Grandway Technology (Shenzhen) Limited · 2015

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2013high 4 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 12 · See all

K120675Digital Automatic Blood Pressure Monitor BPM11 SeriesGrandway Technology (Shenzhen) Limited · 2013 · cites it directly10descendants
K133619Digital Automatic Blood Pressure Monitor BPM18 SeriesGrandway Technology (Shenzhen) Limited · 2014 · 2 generations on8descendants
K143735Digital Automatic Blood Pressure Monitor MD2300Grandway Technology (Shenzhen) Limited · 2015 · 3 generations on3descendants
K163679Digital Automatic Blood Pressure Monitor MD3600Grandway Technology (Shenzhen) Limited · 2017 · 4 generations on1descendant
K150373Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]Grandway Technology (Shenzhen) Limited · 2015 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001670	Automatic Blood Pressure Monitor with Intellisense, Model Hem-757	Omron Healthcare, Inc.	2000	—
0 (this device)	K033397	Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY	Avita Corporation	2004	—
+1	K120675	Digital Automatic Blood Pressure Monitor BPM11 Series	Grandway Technology (Shenzhen) Limited	2013	—
+2	K133619	Digital Automatic Blood Pressure Monitor BPM18 Series	Grandway Technology (Shenzhen) Limited	2014	—
+3	K143735	Digital Automatic Blood Pressure Monitor MD2300	Grandway Technology (Shenzhen) Limited	2015	—
+4	K163679	Digital Automatic Blood Pressure Monitor MD3600	Grandway Technology (Shenzhen) Limited	2017	—
+3	K150373	Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.…	Grandway Technology (Shenzhen) Limited	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	3	0
2014	1	0
2015	4	0
2017	3	0
2019	1	0

FIG. 1 — Lineage of K033397, 2000–2019Source: 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
*	K001670	Automatic Blood Pressure Monitor with Intellisense, Model Hem-757	Omron Healthcare, Inc.	2000	—

Also cleared against K001670: 4 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K120675	Digital Automatic Blood Pressure Monitor BPM11 Series	Grandway Technology (Shenzhen) Limited	2013	10
K123073	Digital Automatic Blood Pressure Monitor BPM03 Series Model MD03X0	Grandway Technology (Shenzhen) Limited	2013	0

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.
Of its descendants, K120675 (Grandway Technology (Shenzhen) Limited, 2013) has gone furthest, with 10 descendants of its own.
4 other devices also cite its predicate K001670.

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?

The device is noninvasive and provides systolic, diastolic blood pressure and pulse rate measurements by using an cuff which is wrapped around the arm. All values can be read out in one LCD panel. Measurement is for adult only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033397 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033397: Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033397

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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