510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NDCClass II

Calculator, Drug Dose

21 CFR 868.1890 / Anesthesiology
FDA source (opens on fda.gov)

NDC is the FDA product code for Calculator, Drug Dose, a class II device type, regulated under 21 CFR 868.1890. As of , FDA records hold 55 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
NDC
Device name
Calculator, Drug Dose
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
55
Ingested recalls
13

Clearances, product code NDC

By decision year
55 clearances under product code NDC with a decision year between 1986 and 2026, 2017 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code NDC by decision year
YearClearances
19863
19882
20001
20011
20051
20062
20071
20082
20101
20122
20143
20153
20162
20178
20183
20191
20205
20213
20233
20243
20252
20263

Applicants with the most clearances

Product code NDC
Applicants holding the most 510(k) clearances under product code NDC
ApplicantClearances
Monarch Medical Technologies6
Voluntis5
Companion Medical, Inc.4
Glytec, LLC3
Glooko Inc2
Medtronic, Inc.2
Roche Diagnostics GmbH2
Sanofi S.r.l.2
Welldoc2
Abbott Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order