510(k) Report

510(k) · Cleared

Cleared

Slip-Pruf-Clinger

K913049510(k) TraditionalCleared Sep 11, 199164-day reviewClass I21 CFR 878.4800

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

Macbrud Corp. Medical Div. · KDD Kit, Surgical Instrument, Disposable

Cleared on Sep 11, 1991 after a 64-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Sep 11, 1991
Review
64 days
Class
Class I
Product code
KDD
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 K913049Source: 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.

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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 KDD devices

KDD Kit, Surgical Instrument, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDD

1in 2008

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

2026 to Oct 25, outlined.

Median 510(k) review, days · KDD

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

Recalls per year · KDD

12so far in 2026, the most since 2007

2007: 22008: 52009: 72010: 42012: 12015: 32017: 22019: 12022: 12023: 12024: 52025: 12026 (partial year): 12, 1 Class I
2007high 12 (2026) · low 0 (2011)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KDD

33in 2025

2010: 32011: 82012: 52013: 442014: 252015: 542016: 332017: 122018: 172019: 222020: 442021: 632022: 122023: 432024: 582025: 33
2007high 63 (2021) · low 0 (2007)2025

MAUDE reports naming product code KDD, 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—20
20081—50
20090—70
20100—43
20110—08
20120—15
20130—044
20140—025
20150—354
20160—033
20170—212
20180—017
20190—122
20200—044
20210—063
20220—112
20230—143
20240—558
20250—133
20260—12 (1)—
Cite this page

510(k) Report. “K913049: Slip-Pruf-Clinger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913049

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