# K120261: PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI Pressure Injectable Safety Huber

- Pathway: 510(k) (Traditional)
- Applicant: Perouse Medical
- Decided: May 2, 2012 after 96 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082306: Powerloc Clear Safety Infusion Set, C.R. Bard, Inc. (2008) Summary page 1.
- K063631: Polyperf / Polyperf Safe, Laboratoires Perouse (2007). Our reading of the summary gave K053631, FDA’s number for Contour Transtar Curved Cutter Stapler Set (Ethicon Endo-Surgery, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Polyperf Safe”.

## Indications for use
The PPS PI* curved safety Huber needle is indicated for: Administration or withdrawal of fluids through implanted ports. -Pressure injection of contrast media into the central venous system only with an implantable infusion port that is also indicated for pressure injection. -The maximum recommended infusion rate at 11,8 cP is - 5 mL/sec. for 19 Ga. needle - 5 mt/sec. for 20 Ga. needle - 2 mt/sec. for 22 Ga. needle. -The PPS P1' Curved Safety Huber needle is indicated to prevent blood-borne pathogen exposures caused by accidental needle punctures. The PPS Pl* Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.

Source page: https://510kreport.com/device/K120261
Methodology: https://510kreport.com/methodology