Cleared Traditional

K894786 - BIO-INDUSTRY STIM POCHE(R)

K894786 is an FDA 510(k) clearance for BIO-INDUSTRY STIM POCHE, manufactured by The Hader Corp.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K894786 · The Hader Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
59d
Days
Class 2
Risk

K894786 is an FDA 510(k) clearance for the BIO-INDUSTRY STIM POCHE(R). Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by The Hader Corp. (Potomac, US). The FDA issued a Cleared decision on September 29, 1989 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - the FDA anesthesiology and respiratory 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.

FDA 510(k) Submission Details - K894786

510(k) Number K894786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1989
Decision Date September 29, 1989
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXN Device Classification - Class 2, Special Controls

Product Code BXN Stimulator, Nerve, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BXN Stimulator, Nerve, Battery-powered

All 35
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K894786.
MS-III MINISTIM
K913184 · Life-Tech Intl., Inc. · Oct 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · Utah Medical Products, Inc. · Jun 1991
MODIFIED AXOSTIM
K896368 · Singer Medical Products, Inc. · Nov 1989
ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR
K893485 · Biometer Intl. A/S · Jul 1989
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
K883868 · Fisher & Paykel Electronics , Ltd. · Nov 1988
TRACER
K881842 · Life-Tech Intl., Inc. · Aug 1988
K894786 · BIO-INDUSTRY STIM POCHE(R)
Download PDF The Hader Corp.