Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- CAHFilter, Bacterial, Breathing-Circuit2Product Code
- K241339Besmed Bacterial Filter and HMEF2Cleared 510(K)
- K222917Breathing circuit bacterial/viral filter2Cleared 510(K)
- K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)2Cleared 510(K)
- K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)2Cleared 510(K)
- K221472Filter and HME/Filter2Cleared 510(K)
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus2Cleared 510(K)
- K221250EasyOne Filter2Cleared 510(K)
- K210352GGM Breathing Circuit Bacterial Filter2Cleared 510(K)
- K211286Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger2Cleared 510(K)
- K202459Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter2Cleared 510(K)
Show All 200 Submissions
- MAJCatheter, Percutaneous, Intraspinal, Short Term2Product Code
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)1Product Code
- LEYSet, Oral Administration2Product Code
- NIHDisinfectant, Subsystem, Water Purification2Product Code
- NIIDisinfectant, Dialysate Delivery System2Product Code
- FLJUnit, Airflow, Laminar2Product Code
- FRTUnit, Isolation, Surgical2Product Code
- FYDApparatus, Exhaust, Surgical2Product Code
- ORCAir Filter Portable Apparatus2Product Code
- QGIAir-Handling Apparatus Accessory1Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
- Page Type
- Cleared 510(K)
- 510(k) Number
- K202459
- 510(k) Type
- Traditional
- Applicant
- Pharma System AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/26/2021
- Days to Decision
- 395 days
- Submission Type
- Summary