510(k) Report

FDA product code · General hospital

Administrations Sets With Neuraxial Connectors

PWHClass II21 CFR 880.5440510(k) required4 decisions since 20170 recalls

4 FDA decisions since 2017. 510(k) reviews decided 2021–2025 took a median of 310 days (half between 245 and 376). No recall names this code. The most-cited predicate is K162219, named by 1 later device.

The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general hospital panel

Twenty years of PWH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PWH

1in 2023

2017: 12018: 12021: 12023: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PWH

Too few PWH 510(k)s in any year since 2007 to give a median.

Recalls per year · PWH

No recall names PWH since 2007.

Adverse event reports per year · PWH

8in 2025

2020: 52021: 52022: 172023: 22024: 162025: 8
2007high 17 (2022) · low 0 (2007)2025

MAUDE reports naming product code PWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20181—00
20190—00
20200—05
20211—05
20220—017
20231—02
20240—016
20250—08
20260—0—
FIG. 1 — PWH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PWH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PWH devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 20171cites it
  • K172592CADD Yellow High Volume Administration Set with NRFit connectorSmiths Medical Asd, Inc. · 20181cites it

Which PWH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K211649PCEA Syringe SetBaxter Healthcare Corporation · 20214generations
  • K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 20173generations
  • K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion · 20232generations
  • K172592CADD Yellow High Volume Administration Set with NRFit connectorSmiths Medical Asd, Inc. · 20181generation

What has FDA decided in PWH lately?

  • K221319BD Alaris™ Pump Epidural Infusion SetCare Fusion · 2023
  • K211649PCEA Syringe SetBaxter Healthcare Corporation · 2021
  • K172592CADD Yellow High Volume Administration Set with NRFit connectorSmiths Medical Asd, Inc. · 2018
  • K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 20171 Class I recall

All 4 PWH decisions →

Related product codes

Other codes under 21 CFR 880.5440.

POQ Blood Transfusion KitFMG Stopcock, I.V. SetPWQ Buret Administration Intravenous KitOJA Intravenous Extension Tubing SetFPK Tubing, Fluid DeliveryFPA Set, Administration, IntravascularCAK Microfilter, Blood TransfusionNEP System/Device, Pharmacy CompoundingMJF Check Valve, Retrograde Flow (In-Line)PYR Neuraxial Administration Set - Intrathecal…LHI Set, I.V. Fluid TransferODI Administration Set Docking Station