510(k) Report

510(k) · Cleared

Cleared

Neo-Link, Disposable Neonatal Air Way Connector

K952824510(k) TraditionalCleared Jul 20, 199530-day reviewClass I21 CFR 868.5810

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

Intertex Medical, Inc. · BZA Connector, Airway (Extension)

Cleared on Jul 20, 1995 after a 30-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 20, 1995
Review
30 days
Class
Class I
Product code
BZA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K952824Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZA? 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?

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

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 BZA devices

BZA Connector, Airway (Extension): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZA

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZA

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

Recalls per year · BZA

4in 2025

2009: 62019: 42024: 22025: 4, 4 Class I
2007high 6 (2009) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · BZA

25in 2025

2007: 82008: 92009: 172010: 92011: 32012: 822013: 112014: 172015: 212016: 52017: 192018: 152019: 132020: 212021: 152022: 212023: 382024: 282025: 25
2007high 82 (2012) · low 3 (2011)2025

MAUDE reports naming product code BZA, 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—08
20080—09
20091—617
20100—09
20110—03
20120—082
20130—011
20140—017
20150—021
20160—05
20170—019
20180—015
20190—413
20200—021
20210—015
20220—021
20230—038
20240—228
20250—4 (4)25
20260—0—

Recent decisions in BZA

The BZA category page

  • K083702Trach-AssistMergenet Medical · 2009
  • K954383Sureloc Circuit ConnectorPolamedco, Inc. · 1995
  • K954197Disposable Flex TubeEngstrom Medical · 1995
  • K953786Unicor, Inc. Connectors & Airway ExtensionsUnicor, Inc. · 1995
  • K951345Disposable Airway Connectors for Gas SamplingCatheter Research, Inc. · 1995

https://510kreport.com/device/K952824 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952824: Neo-Link, Disposable Neonatal Air Way Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952824

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