FDA product code JDY: Evacuator, Vapor, Cement Monomer
JDY is the FDA product code for evacuator, vapor, cement monomer. It is a Class I device, regulated under 21 CFR 888.4220 and reviewed by the Orthopedic panel. FDA has cleared 8 510(k) submissions under JDY, from 7 different applicants. The average 510(k) review took 74 days (median 19). FDA has posted 1 recall for JDY devices.
Classification
| Field | Value |
|---|---|
| Device name | Evacuator, Vapor, Cement Monomer |
| Device class | Class I |
| Regulation | 21 CFR 888.4220 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JDY clearance
Top JDY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 2 | 1977-07-21 |
| Arbor Technologies, Inc. | 1 | 1991-01-04 |
| Hollister, Inc. | 1 | 1990-10-30 |
| Lifestream Int'L, Inc. | 1 | 1986-07-23 |
| Walgen Medical Innoventions | 1 | 1981-03-13 |
2 more applicants have JDY clearances. See the full list in Caduvo.
Most recent JDY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902167 | Arbor Technologies, Inc. | CONTAIN(TM) LASER PLUME FILTER | 1991-01-04 | 234 |
| K902056 | Hollister, Inc. | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER | 1990-10-30 | 176 |
| K862509 | Lifestream Int'L, Inc. | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | 1986-07-23 | 22 |
| K810542 | Walgen Medical Innoventions | CEMENT FUME EVACUATOR TANK & FILTER | 1981-03-13 | 14 |
| K790877 | Stackhouse Assoc. | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | 1979-05-23 | 16 |
Recalls for JDY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-06-30.
Frequently asked questions
What is FDA product code JDY?
JDY is the FDA product code for evacuator, vapor, cement monomer. It is a Class I device, regulated under 21 CFR 888.4220 and reviewed by the Orthopedic panel.
What device class is JDY?
Class I, regulation 21 CFR 888.4220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JDY?
Across 8 cleared submissions the average was 74 days from receipt to decision (median 19).
Which companies have the most JDY clearances?
Howmedica Corp. (2); Arbor Technologies, Inc. (1); Hollister, Inc. (1); Lifestream Int'L, Inc. (1); Walgen Medical Innoventions (1).
Have JDY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JDY
- Run a recall and safety report across every JDY manufacturer
- Watch product code JDY 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.
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