Cleared Traditional

K882244 - RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT

K882244 is an FDA 510(k) clearance for RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT, manufactured by Richards Medical Co., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EPP cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K882244 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Jun 1988
Decision
23d
Days
Class 1
Risk

K882244 is an FDA 510(k) clearance for the RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT. Classified as Splint, Nasal (product code EPP), Class I - General Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on June 23, 1988 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5800 - the FDA ear, nose and throat 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K882244

510(k) Number K882244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1988
Decision Date June 23, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

EPP Device Classification - Class 1, General Controls

Product Code EPP Splint, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EPP Splint, Nasal

All 8
Devices cleared under the same product code (EPP) and FDA review panel - the closest regulatory comparables to K882244.
'EXMOOR' ATKINS NASAL SPLINT
K864930 · Exmoor Plastics , Ltd. · Mar 1987
'EXMOOR' CAWOOD NASAL SPLINTS
K864932 · Exmoor Plastics , Ltd. · Mar 1987
'EXMOOR' SHAH & MACKAY NASAL SPLINTS
K864933 · Exmoor Plastics , Ltd. · Mar 1987
'EXMOOR' SHAH SILICONE DISCS
K864934 · Exmoor Plastics , Ltd. · Jan 1987
CANNON NASAL SPLINT
K863382 · Treace Medical, Inc. · Oct 1986
MICROTEK INTRANASAL SPLINT
K862496 · Microtek Medical, Inc. · Jul 1986