Cleared Traditional

Pluski Safe 1 Safety IV Catheter (K210037) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K210037 · Mediplus (India) Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
443d
Days
Class 2
Risk

K210037 is an FDA 510(k) clearance for the Pluski Safe 1 Safety IV Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Mediplus (India) Limited (Bahadurgarh, IN). The FDA issued a Cleared decision on March 25, 2022 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Mediplus (India) Limited devices

Submission Details

510(k) Number K210037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2021
Decision Date March 25, 2022
Days to Decision 443 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
314d slower than avg
Panel avg: 129d · This submission: 443d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 138
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K210037.
Introcan Safety 2 IV Catheter
K220756 · B.Braun Medical, Inc. · Jun 2022
Introcan Safety IV Catheter
K220626 · B.Braun Medical, Inc. · May 2022
BD Cathena Safety IV Catheter
K220584 · Becton Dickinson Infusion Therapy Systems, Inc. · Mar 2022
B. Braun Introcan Safety 2 IV Catheter
K213664 · B.Braun Medical, Inc. · Feb 2022
Introcan Safety 3 Closed IV Catheter
K213085 · B.Braun Medical, Inc. · Oct 2021
Disposable IV catheter
K202060 · Shinva Ande Healthcare Apparatus Co., Ltd. · Jul 2021