510(k) Report

510(k) · Cleared

Cleared

Saline Solution- Sterile

K922033510(k) TraditionalCleared Jul 21, 199281-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

Trinity Laboratories, Inc. · CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Cleared on Jul 21, 1992 after an 81-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.

Decided
Jul 21, 1992
Review
81 days
Class
Class I
Product code
CCQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK922033 Saline Solution- SterileTrinity Laboratories, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK981905 Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water-…Acu-Pak · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K981905Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO. 10291Acu-Pak · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922033Saline Solution- SterileTrinity Laboratories, Inc.1992—
+1K981905Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO.…Acu-Pak1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K922033, 1992–1998Source: FDA 510(k) summaries, read by 510(k) Report · 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 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?

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
K981905Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO. 10291Acu-Pak19980

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.

What does this lineage say?

  • Of its descendants, K981905 (Acu-Pak, 1998) has gone furthest, with 0 descendants of its own.

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 Trinity Laboratories, Inc.

44 FDA decisions under this applicant name. See the company

  • K981441Heart Cath Tray, Sterile, DisposableTrinity Laboratories, Inc. · 1998
  • K974238Dental Tray, Sterile, DisposableTrinity Laboratories, Inc. · 1998
  • K974286Circumcision Tray, Cat. NO. 70340Trinity Laboratories, Inc. · 1997
  • K972160CRP-Lex System: C-Reactive Protein Antigen Detection in Serum: Slide Agglutnation Latex TestTrinity Laboratories, Inc. · 1997
  • K970722Eye TrayTrinity Laboratories, Inc. · 1997

Recent decisions in CCQ

The CCQ category page

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https://510kreport.com/device/K922033 · printed Nov 4, 2026

Cite this page

510(k) Report. “K922033: Saline Solution- Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K922033

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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