FDA product code EMX: Balloon, Epistaxis
EMX is the FDA product code for balloon, epistaxis. It is a Class I device, regulated under 21 CFR 874.4100 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 47 510(k) submissions under EMX, 1 in the last five years, from 30 different applicants. The average 510(k) review took 107 days (median 65). FDA has posted 4 recalls for EMX devices.
Classification
| Field | Value |
|---|---|
| Device name | Balloon, Epistaxis |
| Device class | Class I |
| Regulation | 21 CFR 874.4100 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for EMX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 283 |
Compare with all 510(k) review times · Search every EMX clearance
Top EMX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ultracell Medical Technologies, Inc. | 5 | 1997-11-18 |
| Shippert Medical Technologies Corp. | 5 | 1996-08-01 |
| Boston Medical Products, Inc. | 4 | 1997-08-04 |
| Les Laboratorires Brothier, S.A. | 2 | 2004-07-01 |
| Invotec International, Inc. | 2 | 1997-05-14 |
25 more applicants have EMX clearances. See the full list in Caduvo.
Most recent EMX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220326 | Hemostasis, LLC | PosiSep X BAM Hemostat Dressing/Intranasal Splint | 2022-11-14 | 283 |
| K041446 | Les Laboratorires Brothier, S.A. | NASALCEASE | 2004-07-01 | 30 |
| K000108 | Bhk Holding | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 | 2000-05-23 | 130 |
| K993362 | Biomatrix, Inc. | HYLASINE | 2000-03-13 | 159 |
| K983276 | Hydrofera, LLC | HYDROFERA BACTERISTATIC NASAL DRESSING | 1999-09-14 | 362 |
Recalls for EMX devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-01-08.
Frequently asked questions
What is FDA product code EMX?
EMX is the FDA product code for balloon, epistaxis. It is a Class I device, regulated under 21 CFR 874.4100 and reviewed by the Ear, Nose and Throat panel.
What device class is EMX?
Class I, regulation 21 CFR 874.4100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMX?
Across 47 cleared submissions the average was 107 days from receipt to decision (median 65).
Which companies have the most EMX clearances?
Ultracell Medical Technologies, Inc. (5); Shippert Medical Technologies Corp. (5); Boston Medical Products, Inc. (4); Les Laboratorires Brothier, S.A. (2); Invotec International, Inc. (2).
Have EMX devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2003-01-08.
Next steps
- Run an FDA pathway report with predicate devices for product code EMX
- Run a recall and safety report across every EMX manufacturer
- Watch product code EMX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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