Cleared Traditional

K852442 - PHARMA-PLAST NEEDLE

K852442 is an FDA 510(k) clearance for PHARMA-PLAST NEEDLE, manufactured by Pharma-Plast USA, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K852442 · Pharma-Plast USA, Inc. · General Hospital
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Sep 1985
Decision
102d
Days
Class 2
Risk

K852442 is an FDA 510(k) clearance for the PHARMA-PLAST NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Pharma-Plast USA, Inc. (Canada H3a 2n4, CA). The FDA issued a Cleared decision on September 20, 1985 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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. Standard predicate reliance. 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 Pharma-Plast USA, Inc. devices

FDA 510(k) Submission Details - K852442

510(k) Number K852442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1985
Decision Date September 20, 1985
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 490
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K852442.
MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
K854548 · Sherwood Medical Co. · Feb 1986
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · Sherwood Medical Co. · Feb 1986
HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
K853731 · Gish Biomedical, Inc. · Oct 1985
VASCULAR IMPLANT ACCESS NEEDLE SET
K851103 · Baxter Healthcare Corp · Jul 1985
JMS NEEDLES & JMS SYRINGES
K845043 · Jms Co., Ltd. · Apr 1985
CHURCHILL HABER POINT NEEDLE ADMIN. SET
K850420 · Churchill Corp. · Apr 1985