# K111939: M/29TM - Pressure Injectable

- Pathway: 510(k) (Traditional)
- Applicant: Flexicath, Ltd.
- Decided: Jul 11, 2012 after 369 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 35 ancestors in all.
No later device cites it as a predicate yet.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080793: Firmgrip, Flexicath, Ltd. (2008) Summary page 2.
- K092629: SNM Firmgrip, Flexicath, Ltd. (2009) Summary page 2.
- K100635: Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504, Arrow Intl., Inc. (2010) Summary page 2.

## Indications for use
The Pressure Injectable M/29TM is a Peripherally Inserted Catheter Device which is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling and pressure injection applications such as contrast media injection. The maximum flow rate for Flexicath Pressure Injectable midline catheter may not exceed 5ml/sec.

Source page: https://510kreport.com/device/K111939
Methodology: https://510kreport.com/methodology