510(k) Report

510(k) · Cleared

Cleared

Sterile Water Wet Dressing

K942014510(k) TraditionalCleared May 27, 199431-day review

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

Trinity Laboratories, Inc. · MGF (no longer in FDA’s product-code list)

Cleared on May 27, 1994 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.

Decided
May 27, 1994
Review
31 days
Product code
MGF
Recalls
None
Predicates
0

11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2006: 1 descendant cleared2008: 2 descendants cleared2007: 1 descendant cleared2009: 3 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK942014 Sterile Water Wet DressingTrinity Laboratories, Inc. · 1994
  2. Descendant · cites it directly · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
  3. Descendant · 2 generations on · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
  4. Descendant · 3 generations on · 5 of its ownK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
  5. Descendant · 2 generations on · 4 of its ownK071663 VF Gel PlusCoapt Systems, Inc. · 2008
  6. Descendant · 3 generations on · 3 of its ownK080956 Modification to VF Gel PlusCoapt Systems, Inc. · 2008

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12007: 12008: 22009: 32013: 12018: 12024: 1
2003high 3 (2009) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all
  • K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · cites it directly10descendants
  • K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 2 generations on6descendants
  • K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · 3 generations on5descendants
  • K071663VF Gel PlusCoapt Systems, Inc. · 2008 · 2 generations on4descendants
  • K080956Modification to VF Gel PlusCoapt Systems, Inc. · 2008 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942014Sterile Water Wet DressingTrinity Laboratories, Inc.1994—
+1K033398Laryngeal Augmentation ImplantBioform, Inc.2003—
+2K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.20061
+3K070090Radiesse Laryngeal ImplantBioform Medical, Inc.2007—
+2K071663VF Gel PlusCoapt Systems, Inc.2008—
+3K080956Modification to VF Gel PlusCoapt Systems, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200710
200820
200930
201310
201810
202410
FIG. 1 — Lineage of K942014, 1994–2024Source: 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.

Planning a device in MGF? 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? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K033398Laryngeal Augmentation ImplantBioform, Inc.200310

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, K033398 (Bioform, Inc., 2003) has gone furthest, with 10 descendants of its own.

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

https://510kreport.com/device/K942014 · printed Nov 3, 2026

Cite this page

510(k) Report. “K942014: Sterile Water Wet Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K942014

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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