Cleared Traditional

K852384 - SIGHT SAVER ALL PURPOSE LENS CARRYING CASE

K852384 · Bausch & Lomb, Inc. · Ophthalmic device

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Jul 1985

Decision

56d

Days

Risk

K852384 is an FDA 510(k) clearance for the SIGHT SAVER ALL PURPOSE LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on July 31, 1985 after a review of 56 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 - K852384

510(k) Number	K852384 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 05, 1985
Decision Date	July 31, 1985
Days to Decision	56 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

54d faster than avg

Panel avg: 110d · This submission: 56d

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 42

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K852384.

HARD CONTACT LENS CLEANING & SOAKING SOLUTION

K853808 · Maurry Biological Co. · Mar 1986

DAILY HARD CONTACT LENS CLEANER

K853809 · Maurry Biological Co. · Mar 1986

UVASORB-400

K854442 · Optatint, Inc. · Feb 1986

SENSITIVE EYES

K832706 · Bausch & Lomb, Inc. · Oct 1983

CLERZ LUBRICATING & REWETTING EYE DROPS

K830740 · CooperVision, Inc. · Jun 1983

PRE-SERT

K822706 · Allergan, Inc. · Oct 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 K852384

Bausch & Lomb, Inc.

Rochester, NY · US

GLENN A DAVIES

Regulatory profile

92 submissions 92 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Bausch & Lomb, Inc. →

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: July 31, 1985. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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