FDA product code GIO: Tube, Collection, Capillary Blood
GIO is the FDA product code for tube, collection, capillary blood. It is a Class I device, regulated under 21 CFR 864.6150 and reviewed by the Hematology panel. FDA has cleared 22 510(k) submissions under GIO, from 13 different applicants. The average 510(k) review took 44 days (median 38). FDA has posted 25 recalls for GIO devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tube, Collection, Capillary Blood |
| Device class | Class I |
| Regulation | 21 CFR 864.6150 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GIO clearance
Top GIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Dade | 5 | 1981-11-06 |
| Sherwood Medical Co. | 3 | 1994-10-27 |
| Medical Technomics, Ltd. | 3 | 1984-11-30 |
| Helps Products, Inc. | 2 | 1988-05-06 |
| Innovative Medical Technologies, Inc. | 1 | 1997-09-22 |
8 more applicants have GIO clearances. See the full list in Caduvo.
Most recent GIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972969 | Innovative Medical Technologies, Inc. | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM | 1997-09-22 | 42 |
| K941291 | Sherwood Medical Co. | MONOJECT SAMPLETTE SEPARATOR TUBE | 1994-10-27 | 224 |
| K894851 | Humagen, Inc. | TRU-TRAX | 1989-09-29 | 60 |
| K885324 | Medical Products Search, Inc. | HEMA(PRO)TEC(TION) | 1989-02-17 | 51 |
| K885138 | Coeur Laboratories, Inc. | CAPILLARY TUBE, BLOOD COLLECTION | 1989-02-07 | 54 |
Recalls for GIO devices
25 product recalls in 7 recall events; 13 initiated in the last five years and 13 still open. Most recent: 2025-09-26.
| Year | Recalls |
|---|---|
| 2020 | 3 |
| 2025 | 13 |
Frequently asked questions
What is FDA product code GIO?
GIO is the FDA product code for tube, collection, capillary blood. It is a Class I device, regulated under 21 CFR 864.6150 and reviewed by the Hematology panel.
What device class is GIO?
Class I, regulation 21 CFR 864.6150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GIO?
Across 22 cleared submissions the average was 44 days from receipt to decision (median 38).
Which companies have the most GIO clearances?
American Dade (5); Sherwood Medical Co. (3); Medical Technomics, Ltd. (3); Helps Products, Inc. (2); Innovative Medical Technologies, Inc. (1).
Have GIO devices been recalled?
Yes: 25 product recalls across 7 recall events; the most recent began 2025-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code GIO
- Run a recall and safety report across every GIO manufacturer
- Watch product code GIO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times