Cleared Traditional

K190013 - WellDoc BlueStar

K190013 is an FDA 510(k) clearance for WellDoc BlueStar, manufactured by Welldoc, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K190013 · Welldoc, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
305d
Days
Class 2
Risk

K190013 is an FDA 510(k) clearance for the WellDoc BlueStar. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on November 4, 2019 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Welldoc, Inc. devices

FDA 510(k) Submission Details - K190013

510(k) Number K190013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2019
Decision Date November 04, 2019
Days to Decision 305 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 129d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 17
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K190013.
RG 3ml Medication Cartridge
K201634 · Chengdu Shifeng Medical Technology Co., Ltd. · Mar 2021
BlueStar Rx
K193654 · Welldoc, Inc. · Apr 2020
SpaceStation MRI
K191910 · B. Braun Melsugen AG · Mar 2020
Lockbox for Perfusor Space PCA Infusion Pump
K173531 · B.Braun Medical, Inc. · Aug 2018
Hospira Sapphire Sets
K160492 · Hospira, Inc. · Dec 2016
ONETOUCH REVEAL
K132618 · Lifescan, Inc. · Dec 2013