Cleared Traditional

K821052 - SOAKARE

K821052 · Allergan, Inc. · Ophthalmic device

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May 1982

Decision

28d

Days

Risk

K821052 is an FDA 510(k) clearance for the SOAKARE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Allergan, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1982 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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 Allergan, Inc. devices

FDA 510(k) Submission Details - K821052

510(k) Number	K821052 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 15, 1982
Decision Date	May 13, 1982
Days to Decision	28 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

82d faster than avg

Panel avg: 110d · This submission: 28d

Pathway characteristics

Predicate-based equivalence.

HPX Device Classification - Class 0,

Product Code	HPX Lens, Contact (polymethylmethacrylate)
Device Class	-

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 19

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K821052.

PRE-SERT

K822706 · Allergan, Inc. · Oct 1982

CLEAN-N-SOAK

K822707 · Allergan, Inc. · Oct 1982

LIQUIFILM WETTING SOLUTION

K821051 · Allergan, Inc. · May 1982

TOTAL

K821054 · Allergan, Inc. · May 1982

BLINK-N-CLEAN

K821055 · Allergan, Inc. · May 1982

BAUSCH & LOMB STERILE ALL PURPOSE SOLU

K820511 · Bausch & Lomb, Inc. · Apr 1982

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K821052

Allergan, Inc.

Mchenry, IL · US

Regulatory profile

33 submissions 33 cleared

100% clearance rate · Active in Ophthalmic

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: May 13, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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