510(k) Report

510(k) · Cleared

Cleared

Dey Vial Sodium Chloride 3%

K972778510(k) TraditionalCleared Oct 8, 199775-day reviewClass II21 CFR 868.5630

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

Dey Laboratories, Inc. · CAF Nebulizer (Direct Patient Interface)

Cleared on Oct 8, 1997 as substantially equivalent to K880411 (Dey Laboratories, Inc., 1988) and 2 other predicates after a 75-day review. Its family tree reaches back 1 generation to 1984. 6 later devices descend from it.

Decided
Oct 8, 1997
Review
75 days
Class
Class II
Product code
CAF
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K841988 (1984). 3 ancestors in all. 6 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1988: 1 other ancestor1984: 1 other ancestor2007: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2021: 1 descendant clearedK841988 · Arm-a-Vial LV Sodium, Chloride Inhalat · Armour Pharmaceutical Co. · 198419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants K841988 · Arm-a-Vial LV Sodium, Chloride Inhalat · Armour Pharmaceutical Co. · 19840
  1. Root · 1 generation backK841988 Arm-a-Vial LV Sodium, Chloride InhalatArmour Pharmaceutical Co. · 1984
  2. This deviceK972778 Dey Vial Sodium Chloride 3%Dey Laboratories, Inc. · 1997
  3. Descendant · cites it directly · 5 of its ownK070498 Hyper SalPari Innovative Manufacturers, Inc. · 2007
  4. Descendant · cites it directly · 4 of its ownK101424 Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010
  5. Descendant · 2 generations on · 0 of its ownK232523 Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024
  6. Descendant · 2 generations on · 0 of its ownK210126 Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021
  7. Descendant · 2 generations on · 0 of its ownK130091 PulmosalPharmacaribe · 2013 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12012: 12013: 12021: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K070498Hyper SalPari Innovative Manufacturers, Inc. · 2007 · cites it directly5descendants
  • K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe · 2010 · cites it directly4descendants
  • K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited · 2024 · 2 generations on0descendants
  • K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation · 2021 · 2 generations on0descendants
  • K130091PulmosalPharmacaribe · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K841988Arm-a-Vial LV Sodium, Chloride InhalatArmour Pharmaceutical Co.1984—
0 (this device)K972778Dey Vial Sodium Chloride 3%Dey Laboratories, Inc.1997—
+1K070498Hyper SalPari Innovative Manufacturers, Inc.2007—
+1K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe2010—
+2K232523Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%Mankind Pharma Limited2024—
+2K210126Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%The Ritedose Corporation2021—
+2K130091PulmosalPharmacaribe20131

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201210
201310
202110
202410
FIG. 1 — Lineage of K972778, 1984–2024Source: 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), 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 CAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CAF device

  1. #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K880411Dey-Vial Sodium Chloride Solution, Usp, Sterile
Summary page 1
…on 10% Common Name: Sodium Chloride Solution 3% Sodium Chloride Solution 10% Classification: Class || Equivalence Claim: DEY-VIAL® Sodium Chloride, USP Sterile 10 mL (K880411) , Arm-A-Vial (Armour, K841988, K841988-A, K841989, K841989-A) (‘ Dis-Pos-Vial (Parke-Davis) Redipak (Wyeth) Device Description:…
Dey Laboratories, Inc.1988—
*K841988Arm-a-Vial LV Sodium, Chloride Inhalat
Summary page 1
…oride Solution 3% Sodium Chloride Solution 10% Classification: Class || Equivalence Claim: DEY-VIAL® Sodium Chloride, USP Sterile 10 mL (K880411) , Arm-A-Vial (Armour, K841988, K841988-A, K841989, K841989-A) (‘ Dis-Pos-Vial (Parke-Davis) Redipak (Wyeth) Device Description: DEY-PAK® Sodium Chloride Solut…
Armour Pharmaceutical Co.1984—
Kept off the family treeK841988-AArm-A-Vial
Number could not be read
Summary page 1
…ution 3% Sodium Chloride Solution 10% Classification: Class || Equivalence Claim: DEY-VIAL® Sodium Chloride, USP Sterile 10 mL (K880411) , Arm-A-Vial (Armour, K841988, K841988-A, K841989, K841989-A) (‘ Dis-Pos-Vial (Parke-Davis) Redipak (Wyeth) Device Description: DEY-PAK® Sodium Chloride Solution 3% and…
*K841989Arm-a-Vial LV Sodium Chloride Inhalat
Summary page 1
…dium Chloride Solution 10% Classification: Class || Equivalence Claim: DEY-VIAL® Sodium Chloride, USP Sterile 10 mL (K880411) , Arm-A-Vial (Armour, K841988, K841988-A, K841989, K841989-A) (‘ Dis-Pos-Vial (Parke-Davis) Redipak (Wyeth) Device Description: DEY-PAK® Sodium Chloride Solution 3% and 10% solut…
Armour Pharmaceutical Co.1984—
Kept off the family treeK841989-AArm-A-Vial
Number could not be read
Summary page 1
…ride Solution 10% Classification: Class || Equivalence Claim: DEY-VIAL® Sodium Chloride, USP Sterile 10 mL (K880411) , Arm-A-Vial (Armour, K841988, K841988-A, K841989, K841989-A) (‘ Dis-Pos-Vial (Parke-Davis) Redipak (Wyeth) Device Description: DEY-PAK® Sodium Chloride Solution 3% and 10% solutions are co…
*—Dis-Pos-Vial
Named without a submission number
—
*—Redipak
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K070498Hyper SalPari Innovative Manufacturers, Inc.20075
K101424Pharmacaribe Inhaled Saline SolutionsPharmacaribe20104
K120051Sodium Chloride Inhalation Solution, 3%, 7%, and 10%, Usp-4MLNephron Pharmaceuticals Corp.20120

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K070498 (Pari Innovative Manufacturers, Inc., 2007) has gone furthest, with 5 descendants of its own.

How does its category compare?

All CAF devices

CAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAF

7in 2025

2007: 182008: 122009: 82010: 102011: 102012: 92013: 92014: 92015: 82016: 52017: 82018: 92019: 32020: 62021: 82022: 42023: 82024: 42025: 72026 (partial year): 2
2007high 18 (2007) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAF

211in 2025

2007: 98 days median2008: 123 days median2009: 163 days median2010: 114 days median2011: 157 days median2012: 126 days median2013: 238 days median2014: 151 days median2015: 186 days median2016: 186 days median2017: 253 days median2018: 161 days median2019: 266 days median2020: 219 days median2021: 324 days median2022: 176 days median2023: 279 days median2024: 251 days median2025: 211 days median
2007high 324 (2021) · low 98 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAF

1in 2018

2007: 12011: 12014: 52015: 32016: 12017: 14, 13 Class I2018: 1
2007high 14 (2017) · low 0 (2008)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · CAF

191in 2025

2007: 262008: 112009: 152010: 372011: 2372012: 1382013: 2172014: 1232015: 1662016: 2012017: 2562018: 1622019: 1852020: 1172021: 1612022: 552023: 1072024: 1022025: 191
2007high 256 (2017) · low 11 (2008)2025

MAUDE reports naming product code CAF, 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
20071898126
200812123011
20098163015
201010114037
2011101571237
201291260138
201392380217
201491515123
201581863166
201651861201
2017825314 (13)256
201891611162
201932660185
202062190117
202183240161
20224176055
202382790107
202442510102
202572110191
20262—0—

What is it indicated for?

Dey Vial Sodium Chloride 3% and 10% are used in conjunction with a nebulizer for the

induction of sputum production where specimen collection is indicated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Dey Laboratories, Inc.

6 FDA decisions under this applicant name. See the company

  • K910239Nebu-Sol Metered Dose Dispenser (TM)Dey Laboratories, Inc. · 1991
  • K880411Dey-Vial Sodium Chloride Solution, Usp, SterileDey Laboratories, Inc. · 1988
  • K875024Dey-Pak and Dey-Vial Sodium Chloride Solution, UspDey Laboratories, Inc. · 1988
  • K875011Dey-Pak Purified Water, Usp, SterileDey Laboratories, Inc. · 1988
  • K831532Ocular Irrigating CannulaDey Laboratories, Inc. · 1983

Recent decisions in CAF

The CAF category page

  • K254171Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210)Shenzhen Mericonn Technology Co., Ltd. · 2026
  • K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o. · 2026
  • K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025
  • K251659Mesh Nebulizer (H6)Qingdao Future Medical Technology Co., Ltd. · 2025
  • K244035Portable mesh nebulizer (JM821)Shenzhen Jermei Medical Device Technology Co., Ltd. · 2025

https://510kreport.com/device/K972778 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972778: Dey Vial Sodium Chloride 3%.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972778

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