Cleared Traditional

K890599 - HOOD NASAL SPLINT

K890599 is an FDA 510(k) clearance for HOOD NASAL SPLINT, manufactured by Hood Laboratories. The device is a Class 1 Ear, Nose, Throat device with product code EPP cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K890599 · Hood Laboratories · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
39d
Days
Class 1
Risk

K890599 is an FDA 510(k) clearance for the HOOD NASAL SPLINT. Classified as Splint, Nasal (product code EPP), Class I - General Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 39 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 Hood Laboratories devices

FDA 510(k) Submission Details - K890599

510(k) Number K890599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1989
Decision Date March 17, 1989
Days to Decision 39 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
51d faster than avg
Panel avg: 90d · This submission: 39d
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 9
Devices cleared under the same product code (EPP) and FDA review panel - the closest regulatory comparables to K890599.
RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT
K882244 · Richards Medical Co., Inc. · Jun 1988
'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