Cleared Traditional

K862365 - NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE

K862365 is an FDA 510(k) clearance for NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE, manufactured by Swemed Laboratories, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HIO cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K862365 · Swemed Laboratories, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
13d
Days
Class 1
Risk

K862365 is an FDA 510(k) clearance for the NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE. Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Swemed Laboratories, Inc. (Sweden, SE). The FDA issued a Cleared decision on July 7, 1986 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1550 - the FDA obstetrics and gynecology 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 Swemed Laboratories, Inc. devices

FDA 510(k) Submission Details - K862365

510(k) Number K862365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1986
Decision Date July 07, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d faster than avg
Panel avg: 160d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

HIO Device Classification - Class 1, General Controls

Product Code HIO Sampler, Amniotic Fluid (amniocentesis Tray)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.1550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HIO Sampler, Amniotic Fluid (amniocentesis Tray)

All 14
Devices cleared under the same product code (HIO) and FDA review panel - the closest regulatory comparables to K862365.
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K896031 · Concord/Portex · Jan 1990
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · Baxter Healthcare Corp · Aug 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846 · Cook Ob/Gyn · Jul 1989
HURWITZ AMNIOCENTESIS NEEDLE
K854725 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1986
PMS AMNIOCENTESIS TRAY/KIT
K850632 · Professional Medical Services · May 1985
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
K844558 · Universal Medical Instrument Corp. · Jan 1985