Cleared Traditional

K844409 - DTL ELECTRODE

K844409 is an FDA 510(k) clearance for DTL ELECTRODE, manufactured by Sauquoit Industries, Inc.. The device is a Class 2 Ophthalmic device with product code HLZ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K844409 · Sauquoit Industries, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
92d
Days
Class 2
Risk

K844409 is an FDA 510(k) clearance for the DTL ELECTRODE. Classified as Electrode, Corneal (product code HLZ), Class II - Special Controls.

Submitted by Sauquoit Industries, Inc. (Scranton, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1220 - the FDA ophthalmic 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 Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sauquoit Industries, Inc. devices

FDA 510(k) Submission Details - K844409

510(k) Number K844409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1984
Decision Date February 14, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLZ Device Classification - Class 2, Special Controls

Product Code HLZ Electrode, Corneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1220
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 Ophthalmic devices follow this clearance model.

Regulatory Peers - HLZ Electrode, Corneal

All 7
Devices cleared under the same product code (HLZ) and FDA review panel - the closest regulatory comparables to K844409.
RM Electrode (RMH 23-01)
K232273 · Retmap, Inc. · Dec 2023
TOMEY DTL ELECTRODE
K961805 · Tomey Corporation USA · May 1997
SOPHER AND BIERER OVUM FORCEPS
K926540 · Thomasville Medical Assoc. · Feb 1994
GOLD FOIL ERG ELECTRODES
K820254 · Cadwell Laboratories, Inc. · Apr 1982
ERG-JET ELECTRODE
K813399 · Nicolet Biomedical Instruments · Jan 1982
MULAR GOLD LEAF ELECTRODE MODEL 7501
K781476 · Life-Tech Instruments, Inc. · Nov 1978