Cleared Traditional

K260620 - SeptAlign (SPLN001)

K260620 is an FDA 510(k) clearance for SeptAlign (SPLN001), manufactured by Spirair, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code NHB cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K260620 · Spirair, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
155d
Days
Class 2
Risk

K260620 is an FDA 510(k) clearance for the SeptAlign (SPLN001). Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Spirair, Inc. (South San Francisco, US). The FDA issued a Cleared decision on July 30, 2026 after a review of 155 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Spirair, Inc. devices

FDA 510(k) Submission Details - K260620

510(k) Number K260620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2026
Decision Date July 30, 2026
Days to Decision 155 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 89d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHB Device Classification - Class 2, Special Controls

Product Code NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

All 9
Devices cleared under the same product code (NHB) and FDA review panel - the closest regulatory comparables to K260620.
SeptAlign
K251790 · Spirair, Inc. · Jan 2026
SeptAlign
K233569 · Spirair, Inc. · Mar 2024
Spirair Nasal Septal Strap
K223167 · Spirair, Inc. · Aug 2023
PosiSep EAR Fragmentable Ear Dressing
K210411 · Hemostasis, LLC · May 2022
LATERA Absorbable Nasal Implant System
K192661 · Entellus Medical, Inc. (Aka Stryker Ent) · Nov 2019
PuraSinus
K183015 · 3-D Matrix, Inc. · Apr 2019