Data / Medical devices / United States / Precision Fluidics Division Parker Hannifin Corp.
Precision Fluidics Division Parker Hannifin Corp.: FDA-registered device maker in Hatfield, PA, United States, 13 510(k) clearances
Precision Fluidics Division Parker Hannifin Corp. is registered with the FDA (registration 2518157) in Hatfield, PA, United States. It lists 15 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 19, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2518157
- Address
- 245 Township Line Rd, Hatfield, PA, United States, 19440
- Owner or operator
- PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. (9915034)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 14, 2001
- Registered through
- 2026
- Brand names listed
- AVS AVS-5000 AUTO VACUUM SWITCH SYSTEM / Automatic Vacuum Switch, AVS AVS-5000B AUTO VAC SWITCH SYS,BRKT MNT / Automatic Vacuum Switch, Bracket Mount, AVS AVS-5000C AUTO VAC SWITCH SYS,CHAIR MNT / Automatic Vacuum Switch, Ball Mount, AVS AVS-5000QD AUTO VAC.SW.SYS-QUICK DISCONN / Automatic Vacuum Switch, Quick Disconnect, AVS AVS-5000S AUTO VAC SWITCH SYS,SWIVEL MNT / Automatic Vacuum Switch, Swivel Mount, Bag Tee - C-1777-000 - BAG TEE ASSY, REMOTE, MIDAS / Midas Remote Bag Tee, Bag Tee - C-1777-001 - BAG TEE ASSY, PORTABLE, MIDAS / Midas Remote Bag Tee, Bag Tee 30157400 BAG TEE ASSY-DIGITAL MDM / Bag Tee for DMDM Flowmeter and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 19, 2024 | K241465 | Midas Flowmeter; eAVS | BZR | Substantially Equivalent | Parker Hannifin Corporation | accessdata.fda.gov |
| March 5, 2023 | K223452 | Nitronox Scavenger Plus | CBN | Substantially Equivalent | Parker Hannifin Corporation | accessdata.fda.gov |
| April 22, 2021 | K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | BZR | Substantially Equivalent | Parker Hannifin | accessdata.fda.gov |
| November 9, 2006 | K062155 | DIGITAL MXR-D FLOWMETER | BSZ | Substantially Equivalent | Porter Instrument Co., Inc. | accessdata.fda.gov |
| September 5, 2006 | K052532 | IMAX 9.5 STERILIZERS | FLE | Substantially Equivalent | Dental X Srl | accessdata.fda.gov |
| June 16, 1998 | K981754 | AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 | CBN | Substantially Equivalent | Porter Instrument Co., Inc. | accessdata.fda.gov |
| December 29, 1994 | K945722 | MATRX MDM, RA | BSZ | Substantially Equivalent | Matrx Medical, Inc. | accessdata.fda.gov |
| June 10, 1993 | K923781 | MXR-2000 FLOWMETER | CAX | Substantially Equivalent | Porter Instrument Co., Inc. | accessdata.fda.gov |
| January 22, 1993 | K922810 | ODYSSEY | BTM | Substantially Equivalent | O-Two Systems Intl., Inc. | accessdata.fda.gov |
| February 17, 1989 | K883833 | NITRONOX(R), FIRST RESPONSE NITRONOX(TM) | BZR | Substantially Equivalent | Matrix Medica, Inc. | accessdata.fda.gov |
| February 9, 1989 | K884879 | CENTURION(TM) MIXER | BSZ | Substantially Equivalent | Matrix Medica, Inc. | accessdata.fda.gov |
| June 25, 1982 | K821744 | FRASER HARLAKE NITRONOX SCAVENGER | CBN | Substantially Equivalent | Fraser Harlake, Inc. | accessdata.fda.gov |
| October 8, 1976 | K760766 | PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER | BZR | Substantially Equivalent | Fraser Sweatman, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 26, 2008 | 49492 | Not yet classified | Terminated | Bag Tee Assembly Model P1407A. An accessory to the dental flowmeter which has a connection function for complete delivery of mixed gases to the breathing circuit portion of the gas scavenging apparatus. The Bag Tee assem | inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas | accessdata.fda.gov |
Compare with other makers
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- All makers of Mask, Gas, Anesthetic
- All makers of Apparatus, Gas-Scavenging
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
Updated September 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.