Cleared Traditional

K881219 - AUTOMATIC PERIMETER, AP-340

K881219 is an FDA 510(k) clearance for AUTOMATIC PERIMETER, manufactured by Kowa Optimed, Inc.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K881219 · Kowa Optimed, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
42d
Days
Class 1
Risk

K881219 is an FDA 510(k) clearance for the AUTOMATIC PERIMETER, AP-340. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Kowa Optimed, Inc. (Torrance, US). The FDA issued a Cleared decision on May 3, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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: 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 - K881219

510(k) Number K881219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1988
Decision Date May 03, 1988
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 110d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

HPT Device Classification - Class 1, General Controls

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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 - HPT Perimeter, Automatic, Ac-powered

All 40
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K881219.
MT-336 AUTOMATIC PERIMETER
K902878 · Marco Technologies · Sep 1990
OPTIFIELD I AND II AUTOMATED PERIMETERS
K884867 · Optimed, Inc. · Mar 1989
OPTIMED ADVANTAGE
K883458 · Optimed, Inc. · Nov 1988
PATTERN DISCRIMINATION PERIMETER
K874336 · Lkc Technologies, Inc. · Jan 1988
TKS 4000 AUTO PERIMETER
K873122 · Vismed, Inc. · Nov 1987
DIGILAB MODEL 1500 PERIMETER
K870120 · Bio-Rad · Feb 1987
K881219 · AUTOMATIC PERIMETER, AP-340
Download PDF Kowa Optimed, Inc.