510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Kung Shin, Hmef SK203

K032878510(k) TraditionalCleared Sep 20, 2004371-day reviewClass II21 CFR 868.5260Recalls 2

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

Kung Shin Plastics Co., Ltd. · CAH Filter, Bacterial, Breathing-Circuit

Cleared on Sep 20, 2004 after a 371-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.

Decided
Sep 20, 2004
Review
371 days
Class
Class II
Product code
CAH
Recalls
2
Predicates
0

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

FIG. 1 — Lineage of K032878Source: FDA 510(k) database · 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 CAH? 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 CAH device

  1. #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 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?

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

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 9, 2025Class IIZ-1269-2025Process designThe machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation.…
Jan 9, 2025Class IIZ-1268-2025Process designThe machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation.…

No ancestor or descendant has a Class I recall.

How does its category compare?

All CAH devices

CAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAH

2in 2024

2007: 22008: 12009: 42010: 52011: 32012: 32013: 12014: 42015: 22017: 12019: 22020: 22021: 22022: 32023: 32024: 22026 (partial year): 2
2007high 5 (2010) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAH

237in 2023

2009: 111 days median2010: 216 days median2011: 281 days median2012: 212 days median2014: 250 days median2022: 204 days median2023: 237 days median
2007high 281 (2011) · low 111 (2009)2026

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

Recalls per year · CAH

1in 2025

2010: 22013: 12014: 12017: 12022: 6, 6 Class I2025: 1, 1 Class I
2007high 6 (2022) · low 0 (2007)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · CAH

77in 2025

2007: 322008: 272009: 182010: 402011: 92012: 162013: 472014: 982015: 512016: 342017: 292018: 332019: 302020: 332021: 562022: 672023: 402024: 512025: 77
2007high 98 (2014) · low 9 (2011)2025

MAUDE reports naming product code CAH, 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—032
20081—027
20094111018
20105216240
2011328109
20123212016
20131—147
20144250198
20152—051
20160—034
20171—129
20180—033
20192—030
20202—033
20212—056
202232046 (6)67
20233237040
20242—051
20250—1 (1)77
20262—0—

What is it indicated for?

The HMEF SK203 is a disposable single-use device indicated for adult patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The HMEF SK203 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in CAH

The CAH category page

  • K252643Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledTeleflex Medical Sdn. Bhd. · 2026
  • K251583Ambu® Virobac II® Exhalation FilterAmbu A/S · 2026
  • K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024
  • K222917Breathing circuit bacterial/viral filterShaoxing Haitech Medical Products Co., Ltd. · 2024
  • K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc. · 2023

https://510kreport.com/device/K032878 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032878: Kung Shin, Hmef SK203.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032878

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