Cleared Traditional

K870193 - A+MED DISPOSABLE NEEDLE

K870193 is an FDA 510(k) clearance for A+MED DISPOSABLE NEEDLE, manufactured by Can-Am Surgical Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K870193 · Can-Am Surgical Corp. · General Hospital
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Feb 1987
Decision
38d
Days
Class 2
Risk

K870193 is an FDA 510(k) clearance for the A+MED DISPOSABLE NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Can-Am Surgical Corp. (Simi Valley, US). The FDA issued a Cleared decision on February 27, 1987 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Can-Am Surgical Corp. devices

FDA 510(k) Submission Details - K870193

510(k) Number K870193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date February 27, 1987
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 492
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K870193.
BLOOD NEEDLE HOLDER
K873569 · Sage Products, Inc. · Nov 1987
NON-CORING HUBER TYPE NEEDLES
K873957 · Advantage Medical Systems, Inc. · Oct 1987
HR (TM) COLLECTION SYSTEM
K872580 · Icu Medical, Inc. · Aug 1987
ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE
K862610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
K861390 · Baxter Healthcare Corp · Jul 1986
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781 · Icu Medical, Inc. · May 1986