510(k) Report

510(k) · Decided

Decided

Abdovac (TM), Bellovac (TM) and Exudrain

K920819510(k) TraditionalDecided Mar 24, 1993394-day reviewClass I21 CFR 878.4680

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

Astra Meditec AB · GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Cleared on Mar 24, 1993 after a 394-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 24, 1993
Review
394 days
Class
Class I
Product code
GCY
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K920819Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCY? 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All GCY devices

GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCY

FDA has decided no GCY device since 2007.

Median 510(k) review, days · GCY

Too few GCY 510(k)s in any year since 2007 to give a median.

Recalls per year · GCY

1in 2018

2008: 382009: 22010: 12011: 122018: 1
2007high 38 (2008) · low 0 (2007)2026

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

Adverse event reports per year · GCY

178in 2025

2007: 2462008: 2052009: 2312010: 1242011: 582012: 472013: 702014: 952015: 932016: 1452017: 2602018: 1802019: 2002020: 2022021: 2162022: 962023: 902024: 742025: 178
2007high 260 (2017) · low 47 (2012)2025

MAUDE reports naming product code GCY, 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
20070—0246
20080—38205
20090—2231
20100—1124
20110—1258
20120—047
20130—070
20140—095
20150—093
20160—0145
20170—0260
20180—1180
20190—0200
20200—0202
20210—0216
20220—096
20230—090
20240—074
20250—0178
20260—0—

More from Astra Meditec AB

3 FDA decisions under this applicant name. See the company

  • K896750Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
  • K882578Astra Dental Implant SystemAstra Meditec AB · 1988

Recent decisions in GCY

The GCY category page

  • K972703Redyrob-Closed Wound Drainage SystemB.Braun Medical, Inc. · 1997
  • K971036Odontit Autogenous Bone Collection DeviceInterpore Intl. · 1997
  • K963839Cordis Suction Reservoir - Model Number: 910-500Cordis Corp. · 1996
  • K960099Penrose Drain Models 6001 - 6007Sil-Med Corp. · 1996
  • K950754Macro Suction Tube Model NO 10061Dlp, Inc. · 1995

https://510kreport.com/device/K920819 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920819: Abdovac (TM), Bellovac (TM) and Exudrain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920819

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026