510(k) Report

510(k) · Cleared

Cleared

TotalShield II Surgical Helmet System

K192194510(k) SpecialCleared Oct 15, 201963-day reviewClass II21 CFR 878.4040

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

Zimmer Surgical, Inc. · FYA Gown, Surgical

Cleared on Oct 15, 2019 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Oct 15, 2019
Review
63 days
Class
Class II
Product code
FYA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2025: 1 descendant cleared201620182020202220242026
  1. This deviceK192194 TotalShield II Surgical Helmet SystemZimmer Surgical, Inc. · 2019
  2. Descendant · cites it directly · 0 of its ownK243522 ViVi® Toga PremiumThi Total Healthcare Innovation GmbH · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K243522ViVi® Toga PremiumThi Total Healthcare Innovation GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K192194TotalShield II Surgical Helmet SystemZimmer Surgical, Inc.2019—
+1K243522ViVi® Toga PremiumThi Total Healthcare Innovation GmbH2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K192194, 2019–2025Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FYA? 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 FYA device

  1. #1 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K243522ViVi® Toga PremiumThi Total Healthcare Innovation GmbH20250

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, K243522 (Thi Total Healthcare Innovation GmbH, 2025) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FYA

4in 2025

2007: 62008: 42009: 62010: 42011: 82012: 42013: 22014: 52015: 32016: 32017: 42018: 22019: 52020: 72021: 172022: 242023: 122024: 52025: 42026 (partial year): 9
2007high 24 (2022) · low 2 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FYA

210in 2025

2007: 110 days median2008: 207 days median2009: 98 days median2010: 128 days median2011: 141 days median2012: 202 days median2014: 120 days median2015: 275 days median2016: 155 days median2017: 111 days median2019: 105 days median2020: 114 days median2021: 163 days median2022: 177 days median2023: 190 days median2024: 163 days median2025: 210 days median2026 (partial year): 198 days median
2007high 275 (2015) · low 98 (2009)2026

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

Recalls per year · FYA

1in 2025

2007: 22010: 22012: 12014: 9, 9 Class I2018: 12020: 402021: 112022: 22023: 12025: 12026 (partial year): 2
2007high 40 (2020) · low 0 (2008)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · FYA

14in 2025

2007: 82008: 32009: 182010: 92011: 162012: 432013: 712014: 422015: 592016: 432017: 662018: 982019: 382020: 312021: 152022: 42023: 122024: 272025: 14
2007high 98 (2018) · low 3 (2008)2025

MAUDE reports naming product code FYA, 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
2007611028
2008420703
2009698018
2010412829
20118141016
20124202143
20132—071
201451209 (9)42
20153275059
20163155043
20174111066
20182—198
20195105038
202071144031
2021171631115
20222417724
202312190112
20245163027
20254210114
202691982—

Recent decisions in FYA

The FYA category page

  • K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle &…Principle & Will Co., Ltd. · 2026
  • K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd. · 2026
  • K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery Studio · 2026
  • K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES) · 2026
  • K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026

https://510kreport.com/device/K192194 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192194: TotalShield II Surgical Helmet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192194

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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