510(k) · Cleared

Cleared

Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat

K884421510(k) TraditionalCleared Jan 13, 198985-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

Pymah Corp. · DXQ Blood Pressure Cuff

Cleared on Jan 13, 1989 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.

Decided: Jan 13, 1989
Review: 85 days
Class: Class II
Product code: DXQ
Recalls: None
Predicates: 0

43 later devices descend from it, 2 citing it directly.

This deviceK884421 Pre-Gaged Balanced Cuff W/Sylgard Antimicro. TreatPymah Corp. · 1989
Descendant · cites it directly · 41 of its ownK071885 Antimicrobial and Single-Patient CuffsPhilips Medical Systems · 2007
Descendant · 2 generations on · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
Descendant · 3 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
Descendant · 4 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
Descendant · 5 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

1999high 6 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 43 · See all

K071885Antimicrobial and Single-Patient CuffsPhilips Medical Systems · 2007 · cites it directly41descendants
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · 2 generations on37descendants
K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 3 generations on36descendants
K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 4 generations on35descendants
K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 5 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K884421	Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat	Pymah Corp.	1989	—
+1	K071885	Antimicrobial and Single-Patient Cuffs	Philips Medical Systems	2007	—
+2	K101600	Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2010	—
+3	K111905	Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN	2011	—
+4	K122223	New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…	Philips Medizin Systeme Boeblingen GmbH	2013	—
+5	K151736	Philips IntelliVue GuardianSoftware	Philips Medizin Systeme Boblingen GmbH	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2007	1	0
2010	1	0
2011	2	0
2013	3	0
2014	1	0
2015	2	0
2017	1	0
2018	2	0
2019	2	0
2020	3	0
2021	2	0
2022	4	0
2023	4	0
2024	6	0
2025	6	0
2026	2	0

FIG. 1 — Lineage of K884421, 1989–2026Source: 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (43)

See all 43

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

Number	Device	Applicant	Decided	Descendants
K071885	Antimicrobial and Single-Patient Cuffs	Philips Medical Systems	2007	41
K990412	Cuff-Able Plus	Vital Signs, Inc.	1999	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?

Of its descendants, K071885 (Philips Medical Systems, 2007) has gone furthest, with 41 descendants of its own.

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	—

https://510kreport.com/device/K884421 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884421: Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884421

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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