510(k) · Cleared

Cleared

BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst

K921048510(k) TraditionalCleared Jul 1, 1993484-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

Colin Medical Instruments Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jul 1, 1993 after a 484-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 102 later devices descend from it.

Decided: Jul 1, 1993
Review: 484 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

102 later devices descend from it, 4 citing it directly.

This deviceK921048 BP8800T/8000IR/8300G Non-Invasive Blood Pres. SystColin Medical Instruments Corp. · 1993
Descendant · cites it directly · 101 of its ownK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
Descendant · cites it directly · 50 of its ownK022537 Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002
Descendant · cites it directly · 46 of its ownK013434 VP-2000/1000Colin Corp. · 2002
Descendant · 2 generations on · 28 of its ownK071645 Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007
Descendant · 2 generations on · 27 of its ownK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

1998high 9 (2015) · low 0 (1999)2026

Most influential descendants

Showing 5 of 102 · See all

K973637Press-Mate AdvantageColin Medical Instruments Corp. · 1998 · cites it directly101descendants
K022537Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002 · cites it directly50descendants
K013434VP-2000/1000Colin Corp. · 2002 · cites it directly46descendants
K071645Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007 · 2 generations on28descendants
K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH · 2008 · 2 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K921048	BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst	Colin Medical Instruments Corp.	1993	—
+1	K973637	Press-Mate Advantage	Colin Medical Instruments Corp.	1998	—
+1	K022537	Press-Mate PM-2100 Vital Sign Monitor	Colin Medical Instruments Corp.	2002	—
+1	K013434	VP-2000/1000	Colin Corp.	2002	—
+2	K071645	Model HBP T-105 Series, Model T-105 and T-105S	Omron Healthcare, Inc.	2007	—
+2	K082357	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp…	Microlife Intellectual Property GmbH	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	2	0
2004	1	0
2005	1	0
2007	2	0
2008	5	0
2010	6	0
2011	5	0
2012	6	0
2013	2	0
2014	3	0
2015	9	0
2016	5	0
2017	5	0
2018	9	0
2019	4	0
2020	3	0
2021	4	0
2022	4	0
2023	6	0
2024	5	0
2025	7	0
2026	7	0

FIG. 1 — Lineage of K921048, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (102)

See all 102

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

Number	Device	Applicant	Decided	Descendants
K973637	Press-Mate Advantage	Colin Medical Instruments Corp.	1998	101
K022537	Press-Mate PM-2100 Vital Sign Monitor	Colin Medical Instruments Corp.	2002	50
K013434	VP-2000/1000	Colin Corp.	2002	46
K032857	Press-Mate BX-10 Vital Sign Monitor	Colin Medical Instruments Corp.	2004	19

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?

Of its descendants, K973637 (Colin Medical Instruments Corp., 1998) has gone furthest, with 101 descendants of its own.

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	—

https://510kreport.com/device/K921048 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921048: BP8800T/8000IR/8300G Non-Invasive Blood Pres. Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921048

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026