# K071885: Antimicrobial and Single-Patient Cuffs

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Dec 20, 2007 after 164 days
- Product code: OED (Antimicrobial Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884421 (1989). 3 ancestors in all.
41 later devices descend from it; 4 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001333: Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact Portable Patient Monitor, Agilent Noni, Agilent Technologies Deutschland GmbH (2000) Summary page 2.
- K901252: Hewlett-Packard Series of Disposable Nibp Cuffs, Hewlett-Packard Co. (1990) Summary page 2.
- K884421: Pre-Gaged Balanced Cuff W/Sylgard Antimicro. Treat, Pymah Corp. (1989) Summary page 2.

## Most influential descendants
- K101600: Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue Patient Monitors MP5, MP2, X2 Model (2010), 37 descendants of its own
- K111905: Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (2011), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K071885
Methodology: https://510kreport.com/methodology