Data / Medical devices / United Kingdom / Pall Newquay
Pall Newquay: FDA-registered device maker in Newquay Cornwall, United Kingdom, 14 510(k) clearances
Pall Newquay is registered with the FDA (registration 9680602) in Newquay Cornwall, United Kingdom. It lists 9 device types. The FDA files 14 510(k) clearances under its listings, the newest dated August 31, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9680602
- FEI number
- 1000268645
- Address
- ST. Columb Major, Newquay Cornwall, United Kingdom, TR9 6TT
- Owner or operator
- Pall Medical (2410597)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 30, 1994
- Registered through
- 2027
- Brand names listed
- Anesthesia Breathing Circuit - Adult Kit 40 Coax, Anesthesia Breathing Circuit - Adult Kit 60 Coax, Anesthesia Breathing Circuit - Adult Kit 72 Coax, Anesthesia Breathing Circuit - Adult Kit 72 Nonexp, Anesthesia Breathing Circuit - Adult Machine Kit 96 2Lbag, Anesthesia Breathing Circuit - Adult Machine Kit 96 2Lbag NCO2, Anesthesia Breathing Circuit - Adult Machine Kit 96 3Lbag, Anesthesia Breathing Circuit - Breathing Bag 2L and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Exhaust, Surgical | FYD | 2 | Manufacturer | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer | accessdata.fda.gov |
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cord Blood Processing System And Storage Container | OAO | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Infusion Line | FPB | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Water Purification, General Medical Use | NHV | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| August 31, 2026 | K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | FPB | Substantially Equivalent | Global Life Sciences Solutions USA, LLC | accessdata.fda.gov |
| November 16, 2021 | K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | CAH | Substantially Equivalent | Pall Corporation | accessdata.fda.gov |
| June 1, 2017 | K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) | NHV | Substantially Equivalent | Pall International Sarl | accessdata.fda.gov |
| June 10, 2016 | K153434 | Pall-Aquasafe Water Filter | NHV | Substantially Equivalent | Pall International Sarl | accessdata.fda.gov |
| August 1, 2002 | K013093 | PALL ULTIPOR ANESTHESIA BREATHING SYSTEM | CAH | Substantially Equivalent | Pall Medical | accessdata.fda.gov |
| December 16, 1999 | K993379 | PALL SUPOR AEF FILTER | FPB | Substantially Equivalent | Pall Corp. | accessdata.fda.gov |
| August 20, 1999 | K992361 | PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 | FYD | Substantially Equivalent | Pall Medical | accessdata.fda.gov |
| September 6, 1994 | K941589 | SYRINGE FILTER DEVICES | FMF | Substantially Equivalent | Gelman Sciences, Inc. | accessdata.fda.gov |
| July 26, 1994 | K942275 | VIAL VENT FILTER | FPB | Substantially Equivalent | Gelman Sciences, Inc. | accessdata.fda.gov |
| June 13, 1991 | K905794 | PALL 3N1 FILTER | FPB | Substantially Equivalent | Pall Biomedical Products Co. | accessdata.fda.gov |
| November 7, 1985 | K854062 | PALL PULMONARY FUNCTION FILTER | BZG | Substantially Equivalent | Pall Biomedical Products Co. | accessdata.fda.gov |
| April 9, 1985 | K850825 | AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR | FPB | Substantially Equivalent | Pall Biomedical Products Co. | accessdata.fda.gov |
| January 21, 1981 | K802765 | ACRODISC FILTER ASSEMBLY | FPB | Substantially Equivalent | Gelman Sciences, Inc. | accessdata.fda.gov |
| August 3, 1979 | K791307 | UNIPOR BREATHING CIRCUIT FILTER | CAH | Substantially Equivalent | Pall Biomedical Products Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Exhaust, Surgical
- All makers of Container, Empty, For Collection & Processing Of Blood & Blood Components
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Syringe, Piston
- All makers of Cord Blood Processing System And Storage Container
- All makers of Filter, Infusion Line
Updated August 31, 2026. 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.