510(k) Report

510(k) · Cleared

Cleared

Bactec 13A Medium (7H13)

K863191510(k) TraditionalCleared Sep 15, 198627-day reviewClass I21 CFR 866.2360

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

Bd Becton Dickinson Vacutainer Systems Preanalytic · JSJ Culture Media, Selective And Non-Differential

Cleared on Sep 15, 1986 after a 27-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
Sep 15, 1986
Review
27 days
Class
Class I
Product code
JSJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared1998: 1 descendant cleared1990200020102020
  1. This deviceK863191 Bactec 13A Medium (7H13)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1986
  2. Descendant · cites it directly · 0 of its ownK983772 MB/Bact Blood Culture BottleOrganon Teknika Corp. · 1999
  3. Descendant · cites it directly · 0 of its ownK982263 MB/Bact Blood Culture BottleOrganon Teknika Corp. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K983772MB/Bact Blood Culture BottleOrganon Teknika Corp. · 1999 · cites it directly0descendants
  • K982263MB/Bact Blood Culture BottleOrganon Teknika Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863191Bactec 13A Medium (7H13)Bd Becton Dickinson Vacutainer Systems Preanalytic1986—
+1K983772MB/Bact Blood Culture BottleOrganon Teknika Corp.1999—
+1K982263MB/Bact Blood Culture BottleOrganon Teknika Corp.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
FIG. 1 — Lineage of K863191, 1986–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JSJ? 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
Get a 510(k) Report

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
K983772MB/Bact Blood Culture BottleOrganon Teknika Corp.19990
K982263MB/Bact Blood Culture BottleOrganon Teknika Corp.19980

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, K983772 (Organon Teknika Corp., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JSJ devices

JSJ Culture Media, Selective And Non-Differential: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSJ

FDA has decided no JSJ device since 2007.

Median 510(k) review, days · JSJ

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

Recalls per year · JSJ

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

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

Adverse event reports per year · JSJ

337in 2025

2018: 22019: 102020: 62021: 462022: 562023: 162024: 192025: 337
2007high 337 (2025) · low 0 (2007)2025

MAUDE reports naming product code JSJ, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—12
20190—010
20200—06
20210—046
20220—056
20230—016
20240—019
20250—0337
20260—0—

More from Bd Becton Dickinson Vacutainer Systems…

656 FDA decisions under this applicant name. See the company

  • K003062Bactec Mgit 960 Sir KitsBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
  • K0035530.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
  • K003461BD Vacutainer Passive Shielding Blood Collection NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 2001
  • K002938B-D Ultra-Fine Iii Pen Needle; Model 31G X 3/16Bd Becton Dickinson Vacutainer Systems Preanalytic · 2000
  • K001364BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000

Recent decisions in JSJ

The JSJ category page

  • K882463Potato Dextrose Agar (Pda) - Product #P3421Lakewood Biochemical Co., Inc. · 1988
  • K881544Littman AgarAcumedia Manufacturers, Inc. · 1988
  • K881571YM BrothAcumedia Manufacturers, Inc. · 1988
  • K881570Sabouraud Maltose AgarAcumedia Manufacturers, Inc. · 1988
  • K881549Mycological Agar W/Low PHAcumedia Manufacturers, Inc. · 1988

https://510kreport.com/device/K863191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K863191: Bactec 13A Medium (7H13).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863191

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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