510(k) Report

510(k) · Cleared

Cleared

Antimicrobial and Single-Patient Cuffs

K071885510(k) TraditionalCleared Dec 20, 2007164-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

Philips Medical Systems · OED Antimicrobial Blood Pressure Cuff

Cleared on Dec 20, 2007 as substantially equivalent to K001333 (Agilent Technologies Deutschland GmbH, 2000) and 2 other predicates after a 164-day review. Its family tree reaches back 1 generation to 1989. 41 later devices descend from it.

Decided
Dec 20, 2007
Review
164 days
Class
Class II
Product code
OED
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K884421 (1989). 3 ancestors in all. 41 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1990: 1 other ancestor2015: 2 descendants cleared2013: 3 descendants cleared2011: 2 descendants cleared2010: 1 descendant cleared2023: 4 descendants cleared2020: 3 descendants cleared2014: 1 descendant cleared2022: 4 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2025: 6 descendants cleared2019: 2 descendants cleared2024: 6 descendants cleared2021: 2 descendants cleared2026: 2 descendants clearedK884421 · Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat · Pymah Corp. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 5 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 4 descendants8 generations forward: 5 descendants9 generations forward: 5 descendants10 generations forward: 6 descendants K884421 · Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat · Pymah Corp. · 19890+5+10
  1. Root · 1 generation backK884421 Pre-Gaged Balanced Cuff W/Sylgard Antimicro. TreatPymah Corp. · 1989
  2. This deviceK071885 Antimicrobial and Single-Patient CuffsPhilips Medical Systems · 2007
  3. Descendant · cites it directly · 37 of its ownK101600 Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  4. Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
  5. Descendant · 3 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  6. Descendant · 4 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
  7. Descendant · 5 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22013: 32014: 12015: 22017: 12018: 22019: 22020: 32021: 22022: 42023: 42024: 62025: 62026: 2
2010high 6 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 41 · See all
  • K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010 · cites it directly37descendants
  • K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
  • K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 3 generations on35descendants
  • K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 4 generations on24descendants
  • K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 5 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884421Pre-Gaged Balanced Cuff W/Sylgard Antimicro. TreatPymah Corp.1989—
0 (this device)K071885Antimicrobial and Single-Patient CuffsPhilips Medical Systems2007—
+1K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010—
+2K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011—
+3K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—
+4K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015—
+5K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201330
201410
201520
201710
201820
201920
202030
202120
202240
202340
202460
202560
202620
FIG. 1 — Lineage of K071885, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OED? 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K001333Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…
Summary page 2
…ame: Cuff, Blood Pressure Reason for submission. Reason for submission Modified Devices Predicates Predicate #1 (K001333) Reusable Non-invasive Blood Pressure Comfort Cuff Predicate #2…
Agilent Technologies Deutschland GmbH2000—
*K901252Hewlett-Packard Series of Disposable Nibp Cuffs
Summary page 2
…Predicate #1 (K001333) Reusable Non-invasive Blood Pressure Comfort Cuff Predicate #2 (K901252) Disposable Non-invasive Blood Pressure Cuff Predicate #3 (K884421) Reusable Non-invasive Blood Pres…
Hewlett-Packard Co.1990—
*K884421Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat
Summary page 2
…t Cuff Predicate #2 (K901252) Disposable Non-invasive Blood Pressure Cuff Predicate #3 (K884421) Reusable Non-invasive Blood Pressure Cuff Comparison of Technological Characteristics The modified devices have…
Pymah Corp.1989—

Also cleared against K001333: 7 other devices →

What descends from it? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037
K152363Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff…Philips Medical Systems20150
K122365Ultracheck Curve Blood Pressure CuffsStatcorp Medical20130
K103637Erka. Perfect-AneroidErka Kallmeyer Medizintechnik GmbH20110

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K101600 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2010) has gone furthest, with 37 descendants of its own.
  • 7 other devices also cite its predicate K001333.

How does its category compare?

All OED devices

OED Antimicrobial Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · OED

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OED

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

Recalls per year · OED

No recall names OED since 2007.

Adverse event reports per year · OED

8in 2025

2022: 12025: 8
2007high 8 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—08
20260—0—

What is it indicated for?

Philips Multi-Patient and Single-Patient cuffs are to be used with identified devices intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric and adult human blood pressure.

Indications for use as stated in the FDA summary.

Also cleared against K001333

7 other devices cite the same predicate.

  • K103637Erka. Perfect-AneroidErka Kallmeyer Medizintechnik GmbH · 2011
  • K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2010
  • K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 20051 recall
  • K051366Piconibp Oem ModulePhilips Medizin Systeme Boeblingen GmbH · 2005
  • K014159Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient MonitorPhilips Medical Systems, Inc. · 2002
  • K013624Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors, Blood Analysis Portal…Philips Medizin Systeme Boblingen GmbH · 2001

More from Philips Medical Systems

127 FDA decisions under this applicant name. See the company

  • P180028/S019HeartStart FRx Defibrillator (861304)Philips Medical Systems · 2026
  • P180028/S018HeartStart FRx DefibrillatorPhilips Medical Systems · 2026
  • P180028/S017HeartStart FRx Defibrillator and HeartStart SMART Pads IIPhilips Medical Systems · 2025
  • P180028/S016HeartStart FRx Defibrillator (861304)Philips Medical Systems · 2025
  • P180028/S015HeartStart FRx DefibrillatorPhilips Medical Systems · 2025

Recent decisions in OED

The OED category page

  • K122365Ultracheck Curve Blood Pressure CuffsStatcorp Medical · 2013

https://510kreport.com/device/K071885 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071885: Antimicrobial and Single-Patient Cuffs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071885

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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