Cleared Traditional

K832529 - M.S.D. ASPIRATOR

K832529 is the FDA 510(k) clearance for M.S.D. ASPIRATOR by Medical Surgical Designs. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K832529 · Medical Surgical Designs · Ophthalmic device
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Jan 1984
Decision
159d
Days
Class 2
Risk

K832529 is an FDA 510(k) clearance for the M.S.D. ASPIRATOR. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Medical Surgical Designs (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 159 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Surgical Designs devices

Submission Details

510(k) Number K832529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date January 04, 1984
Days to Decision 159 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 110d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 113
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K832529.
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K833783 · CooperVision, Inc. · Mar 1984
DISPOSABLE I/A HANDPIECE
K833784 · CooperVision, Inc. · Feb 1984
STORZ EXTRA
K833064 · Storz Instrument Co. · Jan 1984
EPSILON ULTRASONIC TIP
K831836 · CooperVision, Inc. · Jun 1983
ULTRASONIC TIPS
K812126 · CooperVision, Inc. · Sep 1981