Cleared Traditional

K874364 - BAUSCH & LOMB RENU REWETTING & LUBRICAT...

K874364 is the FDA 510(k) clearance for BAUSCH & LOMB RENU REWETTING & LUBRICAT... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K874364 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
33d
Days
Class 2
Risk

K874364 is an FDA 510(k) clearance for the BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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.

View all Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K874364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1987
Decision Date November 25, 1987
Days to Decision 33 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
77d faster than avg
Panel avg: 110d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 35
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K874364.
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · Bausch & Lomb, Inc. · Jan 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · Alcon Laboratories · Dec 1997
OPTI-TEARS(R)
K890303 · Alcon Laboratories · Feb 1989
OPTI-ZYME(R)
K873548 · Alcon Laboratories · Sep 1987
BAUSCH & LOMB CLEANING PAD
K843511 · Bausch & Lomb, Inc. · Oct 1986