510(k) Report

510(k) · Cleared

Cleared

Drager Dve 4000 Series System

K921297510(k) TraditionalCleared Nov 27, 1992255-day reviewClass I21 CFR 878.4960

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

Alm Surgical Equipment, Inc. · FQO Table, Operating-Room, Ac-Powered

Cleared on Nov 27, 1992 after a 255-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 27, 1992
Review
255 days
Class
Class I
Product code
FQO
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1990200020102020
  1. This deviceK921297 Drager Dve 4000 Series SystemAlm Surgical Equipment, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK961886 Drager Gemina Wall-Mounted WorkplaceAlm Surgical Equipment, Inc. · 1996
  3. Descendant · cites it directly · 0 of its ownK961742 Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemAlm Surgical Equipment, Inc. · 1996

Most influential descendants

Showing 2 of 2 · See all
  • K961886Drager Gemina Wall-Mounted WorkplaceAlm Surgical Equipment, Inc. · 1996 · cites it directly0descendants
  • K961742Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemAlm Surgical Equipment, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921297Drager Dve 4000 Series SystemAlm Surgical Equipment, Inc.1992—
+1K961886Drager Gemina Wall-Mounted WorkplaceAlm Surgical Equipment, Inc.1996—
+1K961742Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemAlm Surgical Equipment, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
FIG. 1 — Lineage of K921297, 1992–1996Source: 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 FQO? 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 FQO device

  1. #1 K240598 Maestro System (REF100)score 10.8 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961886Drager Gemina Wall-Mounted WorkplaceAlm Surgical Equipment, Inc.19960
K961742Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemAlm Surgical Equipment, Inc.19960

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, K961886 (Alm Surgical Equipment, Inc., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FQO devices

FQO Table, Operating-Room, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FQO

1in 2024

2009: 12022: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FQO

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

Recalls per year · FQO

8in 2024

2008: 102009: 32010: 32011: 72013: 12014: 12015: 22016: 22018: 52020: 22022: 12023: 22024: 82026 (partial year): 1
2007high 10 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FQO

113in 2025

2007: 612008: 472009: 582010: 1272011: 1012012: 1202013: 1162014: 1452015: 1082016: 932017: 982018: 1042019: 1182020: 972021: 1022022: 1252023: 1872024: 1392025: 113
2007high 187 (2023) · low 47 (2008)2025

MAUDE reports naming product code FQO, 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—061
20080—1047
20091—358
20100—3127
20110—7101
20120—0120
20130—1116
20140—1145
20150—2108
20160—293
20170—098
20180—5104
20190—0118
20200—297
20210—0102
20221—1125
20230—2187
20241—8139
20250—0113
20260—1—

More from Alm Surgical Equipment, Inc.

10 FDA decisions under this applicant name. See the company

  • K982063Alm Prismalix (PRX) Surgical LightAlm Surgical Equipment, Inc. · 19981 recall
  • K961886Drager Gemina Wall-Mounted WorkplaceAlm Surgical Equipment, Inc. · 1996
  • K961742Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemAlm Surgical Equipment, Inc. · 1996
  • K945102Mta:Angenieux Starpoint XE Xenon Light SourceAlm Surgical Equipment, Inc. · 1994
  • K942043Drager Dve 8000/1/2 Series Syst W/Dve 4002 and 8032EAlm Surgical Equipment, Inc. · 1994

Recent decisions in FQO

The FQO category page

  • K240598Maestro System (REF100)Moon Surgical · 2024
  • K221410Maestro PlatformMoon Surgical · 2022
  • K090136Steris Cmax XLT Surgical TableSTERIS Corporation · 20094 recalls
  • K972810OPT80 the Transportable (OPT80)O.P.T. USA, Inc. · 1997
  • K971988Allen, Ultra and Smart SocketsAllen Medical Systems, Inc. · 1997

https://510kreport.com/device/K921297 · printed Nov 5, 2026

Cite this page

510(k) Report. “K921297: Drager Dve 4000 Series System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921297

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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