510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Neonatal Ventilator Circuit

K903083510(k) TraditionalCleared Dec 27, 1990168-day reviewClass I21 CFR 868.5975Recalls 1

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

Hudson Respiratory Care, Inc. · BZO Set, Tubing And Support, Ventilator (W Harness)

Cleared on Dec 27, 1990 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.

Decided
Dec 27, 1990
Review
168 days
Class
Class I
Product code
BZO
Recalls
1
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K903083Source: 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 BZO? 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 has not posted a summary or statement for it, 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)

Recalls of this device

DateClassRecallRoot causeReason
Jul 13, 2026Class IIZ-2992-2026Under Investigation by firmNeonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage.…

No ancestor or descendant has a Class I recall.

How does its category compare?

All BZO devices

BZO Set, Tubing And Support, Ventilator (W Harness): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZO

FDA has decided no BZO device since 2007.

Median 510(k) review, days · BZO

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

Recalls per year · BZO

2so far in 2026, the most since 2007

2012: 1, 1 Class I2025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 2 (2026) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · BZO

70in 2025

2007: 432008: 412009: 462010: 1402011: 1862012: 992013: 1222014: 842015: 552016: 562017: 462018: 262019: 332020: 302021: 522022: 662023: 372024: 452025: 70
2007high 186 (2011) · low 26 (2018)2025

MAUDE reports naming product code BZO, 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—043
20080—041
20090—046
20100—0140
20110—0186
20120—1 (1)99
20130—0122
20140—084
20150—055
20160—056
20170—046
20180—026
20190—033
20200—030
20210—052
20220—066
20230—037
20240—045
20250—1 (1)70
20260—2 (1)—

More from Hudson Respiratory Care, Inc.

15 FDA decisions under this applicant name. See the company

  • K031383MODEL 780Hudson Respiratory Care, Inc. · 20033 recalls
  • K011125Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by HrciHudson Respiratory Care, Inc. · 2001
  • K011134Oxygen Supply Tubing, Model 1115Hudson Respiratory Care, Inc. · 2001
  • K010402Smooth-Flo CircuitHudson Respiratory Care, Inc. · 2001
  • K001213Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60Hudson Respiratory Care, Inc. · 2000

Recent decisions in BZO

The BZO category page

  • K953784Unicor, Inc. Corrugated TubingUnicor, Inc. · 1995
  • K953785Unicor, Inc. Ventilator HosesUnicor, Inc. · 1995
  • K952012Prima Custom Anestesia CircuitPrima, Inc. · 1995
  • K952022Prima Volumn VentilatorssPrima, Inc. · 1995
  • K952011Prima Breathing BagsPrima, Inc. · 1995

https://510kreport.com/device/K903083 · printed Nov 4, 2026

Cite this page

510(k) Report. “K903083: Neonatal Ventilator Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903083

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