510(k) Report

510(k) · Cleared

Cleared

Hypertonic Saline Wet Dressing - Sterile

K941999510(k) TraditionalCleared Jun 29, 199465-day reviewClass I21 CFR 880.5090

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

Trinity Laboratories, Inc. · KMF Bandage, Liquid

Cleared on Jun 29, 1994 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 31 devices in its family, counting itself, has a Class I recall. 30 later devices descend from it.

Decided
Jun 29, 1994
Review
65 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
0

30 later devices descend from it, 1 citing it directly. 1 of the 31 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared2008: 2 descendants cleared, 1 with a Class I recall12005: 2 descendants cleared2007: 2 descendants cleared2014: 3 descendants cleared2013: 1 descendant cleared2009: 1 descendant cleared2019: 1 descendant cleared2018: 2 descendants cleared2016: 3 descendants cleared2017: 3 descendants cleared2022: 1 descendant cleared2025: 3 descendants cleared2026: 3 descendants cleared2023: 2 descendants cleared1990200020102020
  1. This deviceK941999 Hypertonic Saline Wet Dressing - SterileTrinity Laboratories, Inc. · 1994
  2. Descendant · cites it directly · 29 of its ownK040683 Bioderm Sciences Wound DressingBioderm Sciences, Inc. · 2004
  3. Descendant · 2 generations on · 14 of its ownK063063 Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007
  4. Descendant · 2 generations on · 13 of its ownK083355 Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML…Blairex Laboratories, Inc. · 2008
  5. Descendant · 2 generations on · 13 of its ownK042084 Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005
  6. Descendant · 3 generations on · 8 of its ownK131848 Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22007: 22008: 22009: 12013: 12014: 32016: 32017: 32018: 22019: 12022: 12023: 22025: 32026: 3
2004high 3 (2014) · low 0 (2006)2026

Class I recalls in this family

  • K083042 Wound Flush, Sterile Water & Normal Saline3 generations on · 2008

Most influential descendants

Showing 5 of 30 · See all
  • K040683Bioderm Sciences Wound DressingBioderm Sciences, Inc. · 2004 · cites it directly29descendants
  • K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on14descendants
  • K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc. · 2008 · 2 generations on13descendants
  • K042084Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc. · 2005 · 2 generations on13descendants
  • K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc. · 2014 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941999Hypertonic Saline Wet Dressing - SterileTrinity Laboratories, Inc.1994—
+1K040683Bioderm Sciences Wound DressingBioderm Sciences, Inc.2004—
+2K063063Silvacide Skin & Wound Moisturizing SolutionMedical Molecular Therapuetics, LLC2007—
+2K083355Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553Blairex Laboratories, Inc.2008—
+2K042084Bioderm Sciences Wound Healing SprayBioderm Sciences, Inc.2005—
+3K131848Vashe Wound Solution (4.0 OZ), (8.5 OZ & (16.0 OZ)Puricore, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200720
200821
200910
201310
201430
201630
201730
201820
201910
202210
202320
202530
202630
FIG. 1 — Lineage of K941999, 1994–2026Source: 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.

Top candidate predicates for a new KMF device

  1. #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
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? (30)

See all 30

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040683Bioderm Sciences Wound DressingBioderm Sciences, Inc.200429

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.

  • K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K040683 (Bioderm Sciences, Inc., 2004) has gone furthest, with 29 descendants of its own.

How does its category compare?

All KMF devices

KMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMF

1in 2024

2007: 22008: 32009: 32010: 12012: 12014: 22016: 22018: 12019: 12024: 1
2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMF

213in 2009

2008: 35 days median2009: 213 days median
2007high 213 (2009) · low 35 (2008)2026

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

Recalls per year · KMF

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KMF

12in 2025

2007: 62008: 22009: 62010: 72011: 162012: 32013: 342014: 242015: 132016: 182017: 162018: 102019: 62020: 82021: 102022: 72023: 62024: 62025: 12
2007high 34 (2013) · low 2 (2008)2025

MAUDE reports naming product code KMF, 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
20072—16
200833502
2009321306
20101—07
20110—116
20121—03
20130—034
20142—024
20150—013
20162—018
20170—016
20181—010
20191—06
20200—08
20210—010
20220—07
20230—06
20241—06
20250—012
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 KMF

The KMF category page

  • K241916TearRepair Liquid Skin ProtectantOptmed, Inc. · 2024
  • K182733Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019
  • K171148Aleo BME Liquid BandageAleo Bme, Inc. · 2018
  • K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016
  • K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC · 2016

https://510kreport.com/device/K941999 · printed Nov 4, 2026

Cite this page

510(k) Report. “K941999: Hypertonic Saline Wet Dressing - Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K941999

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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