Atlas FDA

Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters

FDA 510(k) clearance K172410 · decided 2018-06-01

Clearance details

K-number
K172410
Device name
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
Applicant
Smiths Medical Asd, Inc.
Decision
Substantially Equivalent
Date received
2017-08-09
Decision date
2018-06-01
Days to decision
296 days
Clearance type
Traditional
Product code
BSP
Device class
2
Regulation number
868.5150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Plymouth, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SonoMSK (K243690)PAJUNK GmbH Medizintechnologie2025-07-01
SonoPlex STIM; SonoPlex II (K243682)PAJUNK GmbH Medizintechnologie2025-06-27
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SonoTAP and SonoTAP II (K243525)PAJUNK GmbH Medizintechnologie2025-03-24
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (K241953)PAJUNK GmbH Medizintechnologie2024-11-22
SonoBlock; SonoBlock II (K241954)PAJUNK GmbH Medizintechnologie2024-09-11
Reach Needle (K240253)Aerin Medical, Inc.2024-03-21
Medispine - Spinal Needle, Glospine - Spinal Needle (K212982)Global Medikit Limited2022-07-29
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (K211085)Becton, Dickinson and Company2022-07-01
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (K210978)Becton, Dickinson and Company2021-12-22
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles (K203668)Myco Medical Supplies, Inc.2021-09-29
DiscCath Needle Set (K212328)Disccath, LLC2021-09-26

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018)Smiths Medical Asd, Inc.2013-05-13
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017)Smiths Medical Asd, Inc.2010-04-21
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016)Smiths Medical Asd, Inc.2009-04-20
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015)Smiths Medical Asd, Inc.2007-11-06
PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014)Smiths Medical Asd, Inc.2007-08-28
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013)Smiths Medical Asd, Inc.2007-04-05
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012)Smiths Medical Asd, Inc.2002-12-17
PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011)Smiths Medical Asd, Inc.2002-10-03