510(k) Report

510(k) · Cleared

Recalled · 2003

Ultracell Nasal Packing

K920358510(k) TraditionalCleared Nov 30, 1992308-day reviewClass I21 CFR 874.4100Recalls 3

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

Ultracell Medical Technologies, Inc. · EMX Balloon, Epistaxis

Cleared on Nov 30, 1992 after a 308-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 3 times.

Decided
Nov 30, 1992
Review
308 days
Class
Class I
Product code
EMX
Recalls
3
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK920358 Ultracell Nasal PackingUltracell Medical Technologies, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK964113 Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal…M-Pact Worldwide Management Corp. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K964113Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing W/Airway Tube &…M-Pact Worldwide Management Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920358Ultracell Nasal PackingUltracell Medical Technologies, Inc.1992—
+1K964113Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing…M-Pact Worldwide Management Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K920358, 1992–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in EMX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EMX device

  1. #1 K220326 PosiSep X BAM Hemostat Dressing/Intranasal…score 4.3 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964113Ivalon Nasal Packing W/Drawstring (8.0CM & 4.5CM), Ivalon Nasal Packing W/Airway Tube &…M-Pact Worldwide Management Corp.19960

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 8, 2003Not classifiedZ-0478-03OtherSterility of the device is compromised
Jan 8, 2003Not classifiedZ-0486-03OtherSterility of the device is compromised
Jan 8, 2003Not classifiedZ-0490-03OtherSterility of the device is compromised

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K964113 (M-Pact Worldwide Management Corp., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EMX devices

EMX Balloon, Epistaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMX

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMX

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

Recalls per year · EMX

No recall names EMX since 2007.

Adverse event reports per year · EMX

16in 2025

2007: 32008: 32009: 32010: 32011: 102012: 12013: 32014: 12016: 12018: 32019: 122020: 52021: 22023: 32024: 122025: 16
2007high 16 (2025) · low 0 (2015)2025

MAUDE reports naming product code EMX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20080—03
20090—03
20100—03
20110—010
20120—01
20130—03
20140—01
20150—00
20160—01
20170—00
20180—03
20190—012
20200—05
20210—02
20221—00
20230—03
20240—012
20250—016
20260—0—

More from Ultracell Medical Technologies, Inc.

24 FDA decisions under this applicant name. See the company

  • K012196Ultracell Absorbent StickUltracell Medical Technologies, Inc. · 2001
  • K972634Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K972633Ultracell Suction SpongeUltracell Medical Technologies, Inc. · 1997
  • K973083Ultracell Neuro SpongesUltracell Medical Technologies, Inc. · 1997
  • K973558Visual Endoscopic Non-Alcohol Ultracell Sponge (Venus)Ultracell Medical Technologies, Inc. · 1997

Recent decisions in EMX

The EMX category page

  • K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC · 2022
  • K041446NasalceaseLes Laboratorires Brothier, S.A. · 2004
  • K000108Rapid Rhino-Anterior 90MM, Model RR-a 90, Rapid Rhino-Posterior 100MM, Model RR-P 100Bhk Holding · 2000
  • K993362HylasineBiomatrix, Inc. · 2000
  • K983276Hydrofera Bacteristatic Nasal DressingHydrofera, LLC · 1999

https://510kreport.com/device/K920358 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920358: Ultracell Nasal Packing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920358

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026