510(k) Report

510(k) · Cleared

Cleared

Pleur-Evac (R) A6000 Adult/Pediatric Chest Drainage

K881252510(k) TraditionalCleared Jun 17, 198886-day reviewClass II21 CFR 880.6740

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

Deknatel, Inc. · GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Cleared on Jun 17, 1988 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Jun 17, 1988
Review
86 days
Class
Class II
Product code
GCX
Recalls
None
Predicates
0

9 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1996: 2 descendants cleared2012: 1 descendant cleared2006: 1 descendant cleared2003: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK881252 Pleur-Evac (R) A6000 Adult/Pediatric Chest DrainageDeknatel, Inc. · 1988
  2. Descendant · cites it directly · 5 of its ownK963850 Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion…Deknatel, Inc. · 1997
  3. Descendant · cites it directly · 5 of its ownK962856 Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model…Deknatel, Inc. · 1996 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK031554 S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion…Genzyme Biosurgery · 2003
  5. Descendant · 2 generations on · 3 of its ownK120953 Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012
  6. Descendant · 3 generations on · 2 of its ownK130043 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1996: 21997: 12003: 12006: 12012: 12013: 12014: 12020: 1
1996high 2 (1996) · low 0 (1998)2026

Most influential descendants

Showing 5 of 9 · See all
  • K963850Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemDeknatel, Inc. · 1997 · cites it directly5descendants
  • K962856Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…Deknatel, Inc. · 1996 · cites it directly5descendants
  • K031554S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemGenzyme Biosurgery · 2003 · 2 generations on4descendants
  • K120953Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012 · 2 generations on3descendants
  • K130043Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881252Pleur-Evac (R) A6000 Adult/Pediatric Chest DrainageDeknatel, Inc.1988—
+1K963850Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemDeknatel, Inc.1997—
+1K962856Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200…Deknatel, Inc.19961
+2K031554S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemGenzyme Biosurgery2003—
+2K120953Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc.2012—
+3K130043Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
200310
200610
201210
201310
201410
202010
FIG. 1 — Lineage of K881252, 1988–2020Source: 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 GCX? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K963850Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemDeknatel, Inc.19975
K962856Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…Deknatel, Inc.19965
K963098Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System (S-100)Deknatel, 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, K963850 (Deknatel, Inc., 1997) has gone furthest, with 5 descendants of its own.

How does its category compare?

All GCX devices

GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCX

FDA has decided no GCX device since 2007.

Median 510(k) review, days · GCX

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

Recalls per year · GCX

1in 2024

2013: 12017: 12023: 32024: 12026 (partial year): 3
2007high 3 (2023) · low 0 (2007)2026

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

Adverse event reports per year · GCX

274in 2025

2007: 242008: 442009: 402010: 512011: 672012: 2422013: 472014: 322015: 522016: 992017: 452018: 502019: 652020: 652021: 652022: 722023: 592024: 652025: 274
2007high 274 (2025) · low 24 (2007)2025

MAUDE reports naming product code GCX, 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—024
20080—044
20090—040
20100—051
20110—067
20120—0242
20130—147
20140—032
20150—052
20160—099
20170—145
20180—050
20190—065
20200—065
20210—065
20220—072
20230—359
20240—165
20250—0274
20260—3—

More from Deknatel, Inc.

77 FDA decisions under this applicant name. See the company

  • K963850Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemDeknatel, Inc. · 1997
  • K962683Snowden-Pencer Computerized High Flow InsufflatorDeknatel, Inc. · 1997
  • K964070Deknatel DSP Pleur-Evac Autotransfusion Blood Recovery BagDeknatel, Inc. · 1996
  • K963098Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System (S-100)Deknatel, Inc. · 1996
  • K962856Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model…Deknatel, Inc. · 19961 recall

Recent decisions in GCX

The GCX category page

  • K042454Stryker Cassette PumpStryker Endoscopy · 20045 recalls
  • K992126Circon Surgiflex Wave Tsunami Suction-Irrigation SystemCircon Corp. · 1999
  • K972074Suction InstrumentationWalter Lorenz Surgical, Inc. · 1997
  • K971022Chase SuckerChase Medical, Inc. · 19971 recall
  • K964127Medi-Vac Flexi-Clear Suction HandleAllegiance Healthcare Corp. · 1996

https://510kreport.com/device/K881252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881252: Pleur-Evac (R) A6000 Adult/Pediatric Chest Drainage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881252

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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