510(k) Report

510(k) · Cleared

Cleared

SinuBand

K160101510(k) TraditionalCleared Jul 27, 2016190-day reviewClass I21 CFR 874.4780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bioinspire Technologies, Incorporated · QJL Splint, Intranasal Septal, Cber Led

Cleared on Jul 27, 2016 as substantially equivalent to K982731 (Xomed, Inc., 1999) and 3 other predicates after a 190-day review. Its family tree reaches back 4 generations to 1997.

Decided
Jul 27, 2016
Review
190 days
Class
Class I
Product code
QJL
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K972082 (1997). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2005: 1 other ancestor1999: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestorK972082 · Custom Nasal Splint · Boston Medical Products, Inc. · 1997K012532 · Sepragel Sinus · Genzyme Corp. · 2001K063308 · Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 · Carbylan Biosurgery · 2006K070496 · Advacoat Sinus Gel and Stent · Carbylan Biosurgery · 200719952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor K070496 · Advacoat Sinus Gel and Stent · Carbylan Biosurgery · 2007K063308 · Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200 · Carbylan Biosurgery · 2006K012532 · Sepragel Sinus · Genzyme Corp. · 2001K972082 · Custom Nasal Splint · Boston Medical Products, Inc. · 19970
  1. Root · 4 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
  2. 3 generations backK012532 Sepragel SinusGenzyme Corp. · 2001
  3. 2 generations backK063308 Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006
  4. 1 generation backK070496 Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
  5. This deviceK160101 SinuBandBioinspire Technologies, Incorporated · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K972082Custom Nasal SplintBoston Medical Products, Inc.1997—
−3K012532Sepragel SinusGenzyme Corp.2001—
−2K063308Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery2006—
−1K070496Advacoat Sinus Gel and StentCarbylan Biosurgery2007—
0 (this device)K160101SinuBandBioinspire Technologies, Incorporated2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200410
200510
200810
FIG. 1 — Lineage of K160101, 1997–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K982731Merogel Nasal Dressing and Sinus Stent
Summary page 5
…• Regulatory Class: I • Product Code: LYA III. PREDICATE DEVICES • MeroGel Nasal Dressing and Sinus Stent (K982731) • AdvaCoat Gel and Stent (K070496) • Synthemed Device (K082276) • NasoPore Nasal Dressing (K…
Xomed, Inc.1999—
*K070496Advacoat Sinus Gel and Stent
Summary page 5
…• Product Code: LYA III. PREDICATE DEVICES • MeroGel Nasal Dressing and Sinus Stent (K982731) • AdvaCoat Gel and Stent (K070496) • Synthemed Device (K082276) • NasoPore Nasal Dressing (K052099) IV. DEVICE DESCRIPTION SinuB…
Carbylan Biosurgery2007—
*K082276Synthemed Device
Summary page 5
…LYA III. PREDICATE DEVICES • MeroGel Nasal Dressing and Sinus Stent (K982731) • AdvaCoat Gel and Stent (K070496) • Synthemed Device (K082276) • NasoPore Nasal Dressing (K052099) IV. DEVICE DESCRIPTION SinuBand is a sterile, single-use, bioresorbab…
Synthemed, Inc.2008—
*K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ
Summary page 5
…l Nasal Dressing and Sinus Stent (K982731) • AdvaCoat Gel and Stent (K070496) • Synthemed Device (K082276) • NasoPore Nasal Dressing (K052099) IV. DEVICE DESCRIPTION SinuBand is a sterile, single-use, bioresorbable two-layer film designed to be a tem…
Polyganics B.V.,2005—

Also cleared against K982731: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
  • None of the 9 ancestors has a recall.
  • 6 other devices also cite its predicate K982731.

How does its category compare?

All QJL devices

QJL Splint, Intranasal Septal, Cber Led: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · QJL

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJL

Too few QJL 510(k)s in any year since 2007 to give a median.

Recalls per year · QJL

No recall names QJL since 2007.

Adverse event reports per year · QJL

No MAUDE report names QJL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions.

Indications for use as stated in the FDA summary.

Also cleared against K982731

6 other devices cite the same predicate.

  • K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2013
  • K070496Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
  • K063308Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006
  • K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
  • K012532Sepragel SinusGenzyme Corp. · 2001
  • K993362HylasineBiomatrix, Inc. · 2000

https://510kreport.com/device/K160101 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160101: SinuBand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160101

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026