510(k) Report

510(k) · Cleared

Cleared

E-Z Spacer Mask (Small)

K964956510(k) TraditionalCleared Apr 23, 1997133-day reviewClass I21 CFR 868.5640

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

Airpharma, LLC · CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Cleared on Apr 23, 1997 after a 133-day review. The FDA summary names no predicate by number.

Decided
Apr 23, 1997
Review
133 days
Class
Class I
Product code
CCQ
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K964956Source: FDA 510(k) database · 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.

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

  • 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?

The FDA summary names no predicate by number.

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.

How does its category compare?

All CCQ devices

CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCQ

FDA has decided no CCQ device since 2007.

Median 510(k) review, days · CCQ

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

Recalls per year · CCQ

5in 2016

2011: 12016: 5
2007high 5 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CCQ

30in 2025

2007: 32008: 52009: 42010: 152011: 102012: 72013: 2072014: 982015: 1322016: 182017: 132019: 42020: 12021: 22023: 72024: 72025: 30
2007high 207 (2013) · low 0 (2018)2025

MAUDE reports naming product code CCQ, 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—05
20090—04
20100—015
20110—110
20120—07
20130—0207
20140—098
20150—0132
20160—518
20170—013
20180—00
20190—04
20200—01
20210—02
20220—00
20230—07
20240—07
20250—030
20260—0—

More from Airpharma, LLC

2 FDA decisions under this applicant name. See the company

  • K933090EZ-SpacerAirpharma, LLC · 1994

Recent decisions in CCQ

The CCQ category page

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  • K961894Mdi TutorMdi Tutor, Inc. · 1996
  • K961455Medshield/AerochamberDiemolding Corp. · 1996
  • K960593Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry Airway, Model Number…Aradigm Corp. · 1996
  • K922033Saline Solution- SterileTrinity Laboratories, Inc. · 1992

https://510kreport.com/device/K964956 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964956: E-Z Spacer Mask (Small).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964956

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