510(k) Report

FDA applicant

Deknatel, Inc.

San Jose-Heredia, CR37 decisions1976–199711 recalls

FDA records 37 decisions for Deknatel, Inc. (San Jose-Heredia, CR) from 1976 to 1997: 37 510(k) clearances. Most are in product codes CAC (Apparatus, Autotransfusion) and KDQ (Bottle, Collection, Vacuum). Its devices cite 23 predicates, 12 of them its own earlier devices. 11 recalls are linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Deknatel, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Deknatel, Inc. since 2007.

Recalls per year

1in 2015

2007: 22014: 82015: 1
2007high 8 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Deknatel, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Deknatel, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • CACApparatus, Autotransfusion11decisions
  • KDQBottle, Collection, Vacuum5decisions
  • GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered4decisions
  • JOLCatheter And Tip, Suction2decisions
  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene2decisions
  • ITGBandage, Cast1decision

Also: GDW (1), GAQ (1), KNT (1), DTN (1), GAL (1), GAP (1).

Whose devices does it build on?

Its devices cite 23 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K930738Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 19949cite it
  • K905768Pleur-Evac Chest Drainage SystemsDeknatel, Inc. · 19913cite it
  • K884844Pleur-Evac (R) a-7002--Adult/Pediatric DrainageDeknatel, Inc. · 19893cite it
  • K854301Pleur-Evac II Autotransfusion SystemDeknatel, Inc. · 19853cite it
  • K881252Pleur-Evac (R) A6000 Adult/Pediatric Chest DrainageDeknatel, Inc. · 19883cite it
  • K962856Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model…Deknatel, Inc. · 19962cite it

What has FDA decided for it lately?

  • 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
  • K925243Deknatel (TM) Pleur-Evac (R) Thoracic CatheterDeknatel, Inc. · 1994
  • K930740Surgical Suture, Nonabsorable Stainless SteelDeknatel, Inc. · 19941 recall
  • K930738Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 19949 recalls

All 37 as Deknatel, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K962856Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx…Mar 13, 2015Class II
  • K930738Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated…Mar 11, 2014Class II
  • K930738Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel…Mar 11, 2014Class II
  • K930738Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic…Mar 11, 2014Class II
  • K930738Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile…Mar 11, 2014Class II
  • K930738Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile…Mar 11, 2014Class II