Cleared Traditional

K821866 - OXY-PMMA

K821866 · Petrarch Systems & Professional Pharm · Ophthalmic device

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Sep 1982

Decision

82d

Days

Risk

K821866 is an FDA 510(k) clearance for the OXY-PMMA. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Petrarch Systems & Professional Pharm (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 82 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.

FDA 510(k) Submission Details - K821866

510(k) Number	K821866 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 1982
Decision Date	September 14, 1982
Days to Decision	82 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

28d faster than avg

Panel avg: 110d · This submission: 82d

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 67

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K821866.

PRE-SERT

K822706 · Allergan, Inc. · Oct 1982

CLEAN-N-SOAK

K822707 · Allergan, Inc. · Oct 1982

LE CASE HARD CONTACT LENS STORAGE CASE

K822495 · Optikem International, Inc. · Sep 1982

LENS EASY ON

K822105 · L.E.O. Corp. · Aug 1982

LIQUIFILM WETTING SOLUTION

K821051 · Allergan, Inc. · May 1982

SOAKARE

K821052 · Allergan, Inc. · May 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 K821866

Petrarch Systems & Professional Pharm

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Petrarch Systems & Professional Pharm →

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: September 14, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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