Cleared Traditional

K844558 - UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE

K844558 is an FDA 510(k) clearance for UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE, manufactured by Universal Medical Instrument Corp.. The device is a Class 1 Obstetrics & Gynecology device with product code HIO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K844558 · Universal Medical Instrument Corp. · Obstetrics & Gynecology device
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Jan 1985
Decision
71d
Days
Class 1
Risk

K844558 is an FDA 510(k) clearance for the UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE. Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Universal Medical Instrument Corp. (Ballston Spa, US). The FDA issued a Cleared decision on January 31, 1985 after a review of 71 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 Universal Medical Instrument Corp. devices

FDA 510(k) Submission Details - K844558

510(k) Number K844558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1984
Decision Date January 31, 1985
Days to Decision 71 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 160d · This submission: 71d
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 13
Devices cleared under the same product code (HIO) and FDA review panel - the closest regulatory comparables to K844558.
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
AMNIO CENTESES KIT W/NEEDLE
K830019 · Universal Medical Instrument Corp. · Jan 1983
AMMOCENTESIS TRAY (KIT)
K761230 · Pharmaseal Div., Baxter Healthcare Corp. · Dec 1976