510(k) Report

510(k) · Cleared

Cleared

Prefilled Respiratory Therapy Vials

K870332510(k) TraditionalCleared Apr 1, 198763-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

Automatic Liquid Packaging, Inc. · CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Cleared on Apr 1, 1987 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.

Decided
Apr 1, 1987
Review
63 days
Class
Class I
Product code
CCQ
Recalls
None
Predicates
0

8 later devices descend from it, 3 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 2 descendants cleared1998: 1 descendant cleared2012: 1 descendant cleared2024: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared, 1 with a Class I recall11990200020102020
  1. This deviceK870332 Prefilled Respiratory Therapy VialsAutomatic Liquid Packaging, Inc. · 1987
  2. Descendant · cites it directly · 5 of its ownK972466 Sodium Chloride Inhalation Solution, UspHolopack International, LP · 1997
  3. Descendant · 2 generations on · 3 of its ownK113033 Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLNephron Pharmaceuticals Corp. · 2012
  4. Descendant · 3 generations on · 1 of its ownK142153 Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution…Teleflexmedical, Inc. · 2015 · Recalled (Class I)
  5. Descendant · 2 generations on · 0 of its ownK232523 Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024
  6. Descendant · 4 generations on · 0 of its ownK231058 Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1997: 21998: 12012: 12013: 12015: 12024: 2
1997high 2 (1997) · low 0 (1999)2026

Class I recalls in this family

  • K142153 Hudson Rci Addipak Unit Dose Vial, 0.9% Full…3 generations on · 2015

Most influential descendants

Showing 5 of 8 · See all
  • K972466Sodium Chloride Inhalation Solution, UspHolopack International, LP · 1997 · cites it directly5descendants
  • K113033Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLNephron Pharmaceuticals Corp. · 2012 · 2 generations on3descendants
  • K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLTeleflexmedical, Inc. · 2015 · 3 generations on1descendant
  • K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024 · 2 generations on0descendants
  • K231058Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870332Prefilled Respiratory Therapy VialsAutomatic Liquid Packaging, Inc.1987—
+1K972466Sodium Chloride Inhalation Solution, UspHolopack International, LP1997—
+2K113033Sodium Chlorde Inhalation Solution, 0.9% Usp-3MLNephron Pharmaceuticals Corp.2012—
+3K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution…Teleflexmedical, Inc.2015Class I
+2K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited2024—
+4K231058Hudson RCI® AddiPak® Unit Dose VialMedline Industries, LP2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
201210
201310
201511
202420
FIG. 1 — Lineage of K870332, 1987–2024Source: 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.

1 device in this family has a Class I recall. 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
Get a 510(k) Report

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? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972466Sodium Chloride Inhalation Solution, UspHolopack International, LP19975
K9740560.9.% Sodium Chloride Inhalation Solution, UspHolopack International, LP19980
K972467Sterile Water for Inhalation, UspHolopack International, LP19970

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K142153Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15MLTeleflexmedical, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K972466 (Holopack International, LP, 1997) has gone furthest, with 5 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 Automatic Liquid Packaging, Inc.

29 FDA decisions under this applicant name. See the company

  • K994321Sterile Water and 0.9% Sodium Chloride for Irrigation, UspAutomatic Liquid Packaging, Inc. · 2000
  • K000964Sterile Water or O.9% Sodium Chloride, Model AL4100 & AL4109Automatic Liquid Packaging, Inc. · 2000
  • K980147Your Choice Multi-Purpose Contact Lens Cleaning SolutionAutomatic Liquid Packaging, Inc. · 1998
  • K973829Irrigation BottleAutomatic Liquid Packaging, Inc. · 1998
  • P850070/S010Sterile Saline Preserved SolutionAutomatic Liquid Packaging, Inc. · 1997

Recent decisions in CCQ

The CCQ category page

  • K972397EZ SprayIntertex Research, Inc. · 1997
  • K964956E-Z Spacer Mask (Small)Airpharma, LLC · 1997
  • 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

https://510kreport.com/device/K870332 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870332: Prefilled Respiratory Therapy Vials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870332

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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